ReyadaPro

Hassan Mostafa
About: Hassan Mostafa - Chairman & Chief Executive Officer at ReyadaPro

Dr. Hassan Mostafa Mohamed, Chairman & Chief Executive Officer at ReyadaPro is an Entrepreneurial and growth-driven executive with more than 25 years of experience in pharmaceutical industries, including, Technical, sales & marketing, Production, Supply chain, Engineering/utilities, Quality, and regulatory issues. Mr. Hassan is an expert in driving pharmaceutical facilities to accomplish corporate goals, building and leading technical & quality aspects with market consideration for rapid growth, and efficient operational excellence.

Addressing challenges in global supply chain logistics in the pharmaceutical industry involves navigating a complex landscape of regulations, quality control standards, and diverse stakeholders.

Key challenges include ensuring product integrity, managing temperature-sensitive medications, mitigating risks of counterfeit drugs, and optimizing distribution networks for timely delivery while minimizing costs.

Solutions include leveraging technology like blockchain for traceability, implementing rigorous quality assurance measures, partnering with dependable logistics providers, and adopting agile supply chain strategies to respond to disruptions effectively.

Collaboration among stakeholders, including manufacturers, distributors, regulatory agencies, and logistics companies, is crucial for overcoming these challenges and ensuring the safe and efficient delivery of pharmaceutical products worldwide.

1. To start, please provide a brief overview of your background and experience in managing global supply chain logistics. Highlight key achievements and the scope of your responsibilities in your most recent role.

My key achievements in this role include:

1. Application and implementation of supply chain optimization strategies to reduce costs and improve efficiency, via the following steps:

a. Adopting advanced planning and scheduling systems.

b. Implementing lean principles

c. Redesigning distribution networks.

2. Adapting the usage of custom logistics operations using full awareness and application of customs regulations, optimizing freight routes, and trying to minimize lead times for shipments globally.

Establish risk management practices aiming to:

a. Ease disruptions by developing contingency plans in case of natural disasters, sudden geopolitical events, or the possibility of supplier failures.

3. Always trying and applying Active continuous improvement initiatives aiming to:

a. Improve supply chain performance, such as vendor-managed inventory system, regular performance reviews with logistics partners, or perform data analytics to identify optimization opportunities.

4. Build and develop strong supplier relationships and/or negotiate beneficial terms to ensure reliable supply at competitive prices.

5. Best use of strategic thinking, operational expertise, and effective collaboration with internal and external stakeholders to deliver value to the organization.

6. Apply a win-win approach with your supplier via the global supply chain to achieve the short and long term of the organization.

2. Share a specific instance where you aligned the global supply chain strategy with the overall business strategy, considering both short-term objectives and long-term goals.

In Saudi Arabia, I was working as a project manager at a local retail company aiming to expand its presence in the Saudi Arabian market, the company’s overall business strategy focused on delivering the missed and highly required drugs such as vaccines and other critical drugs via fast and approved contracting supervised and approved via SFDA to satisfy the shortage of delivery in the supply chain.

We do the following steps to achieve this objective:

1. Short-term Objectives:

a. KSA Market share/penetration:

i. Work closely and collaborate with the marketing team to identify key locations for hospitals and clinical centers.

ii. Identify the importance of fast support for healthcare providers and clinical institutes for the required medications.

b. Market fast response: To achieve the short-term objective we worked on rationalizing the supply chain by enhancing the existing supplier relationships and optimizing transportation routes to minimize lead times.

c. Cost Efficiency: we focused on reducing the cost of delivery via local suppliers and transportation providers, provided that achieving the required quality standards.

2. Long-term Goals:

a. Scalability: identify the supply chain network involved in selecting suppliers and partners capable of supporting future growth and implementing flexible logistics solutions to satisfy urgent and increasing demands.

b. Localization: keep and maintain the local market preferences and regulations, via building our strategy to enhance and satisfy any change in the customer needs whereas we keep and maintain compliance with SFDA laws and regulations.

c. Sustainability: we always do our best to ensure our commitment to sustainability, via cohesive environmentally friendly practices in the supply chain strategy to minimize carbon emissions during transportation and its timing/route of delivery during transportation.

3. In a volatile global market, how do you prioritize and address different types of risks in the supply chain? Provide an example where your risk management approach proved crucial, considering geopolitical, economic, or logistical risks. How we can prioritize and address these above-mentioned risks, along with an example where my risk management approach proved crucial?

Risk Identification and Assessment: this can be applied through the following:

Conduct a thorough risk assessment to identify potential risks across the pharmaceutical supply chain.

Consider the geopolitical factors such as political instability/variability, regulatory changes/updates, and trade distractions; economic factors such as currency variations and market volatility; and logistical factors such as transportation interruptions/delays, supplier instabilities/disturbances, and other natural disasters.

Risk Prioritization:

After we identify the risks, apply prioritization based on the risks' potential impact on the following:

  • Supply chain operations,
  • Patient  safety,
  • Regulatory compliance, and
  • Business continuity.

N.B.: prioritize the risks with the highest likelihood and impact for mitigation efforts.

Risk Mitigation Strategies:

Geopolitical Risks: such as political instability/variability or regulatory changes/updates.

  • Develop contingency plans and alternative sourcing strategies to mitigate the impact on the supply chain.
  • Involve varying suppliers, establishing local production facilities in different regions, or maintaining strategic inventory storage areas.

Economic Risks: Address the economic risks such as currency variations/fluctuations or market volatility.

  • Apply financial protection strategies to reduce the exposure to currency risk and monitor market trends to predict potential economic disruptions/distractions.

Logistical Risks: Such as transportation delays/intervals or supplier disruptions/ disturbances,

  • Apply/execute risk mitigation measures such as inventory optimization, supplier diversification, and contingency planning for alternative transportation routes or logistics collaborators.

Collaboration and Communication: To address risks and implement mitigation measures proactively do the following:

  • Follow and maintain the highest level of collaboration and communication with a variety of stakeholders such as cross-functional teams, suppliers, and logistics collaborators/partners.
  • Establish regular communication channels to monitor risk indicators, assess the effectiveness of mitigation strategies, and adjust plans as required.

Example of Crucial Risk Management Approach:

  • Scenario: Transportation Interruption during the pandemic - coronavirus

During the pandemic, there was a global health crisis, and transportation/shipment of pharmaceutical products experienced a severe disruption due to this crisis, causing delays in the delivery of critical medications to patients around the globe, especially in the affected regions.

Steps to solve this severe and critical situation:

Apply the Risk Management Approach via the following:

  • Rapid Response: activating the crisis management team and establishing communication channels with logistics partners to assess the situation and coordinate response efforts.
  • Contingency Planning: application of the pre-established contingency plans, quick identification of alternative transportation routes, and logistics partners to reroute shipments and minimize delays in delivering critical medications to patients.
  • Collaborative Action: collaborated closely with internal stakeholders, including production teams, regulatory affairs, and customer support, to prioritize shipments based on patient needs, regulatory requirements, and product shelf life considerations.
  • Communication and Transparency: maintain the highest level of transparent communication with customers, healthcare providers, and regulatory authorities, providing regular updates on shipment status, anticipated delays, and mitigation efforts to ensure continued patient access to essential medications.

Outcome:

Through the application of the initiative-taking risk management approach and leveraging collaborative action:

  • Successfully mitigate the impact of the transportation interference caused by the crisis.
  • Ensure the delivery of critical medications to the patients in affected regions without significant delays.
  • Ensure business continuity and patient care during unstable global market conditions through the effectiveness of the risk management strategy.
4. Discuss the successful implementation of advanced technology in the global supply chain. Highlight challenges faced during integration and the positive impact on operational efficiency.

The successful implementation of advanced technology in the global supply chain of pharmaceuticals has brought significant benefits and improvements in operational efficiency.

Implementation Process:

Technology Selection: to apply an effective strategy in technology selection, we should do the following:

  • Align the technology required with the specific needs and objectives of the pharmaceutical supply chain.
  • Proposed and suggested technologies may include blockchain for traceability, Internet of Things (IoT) devices for real-time monitoring, artificial intelligence (AI) for demand forecasting, and robotic process automation (RPA) for streamlining administrative tasks.

Pilot Testing:

  • Conduct  model testing to evaluate the possibility and effectiveness of the selected  technologies in the  controlled environment before commercial application to:
  • Have a clear view of any potential issues or challenges that may arise.
  • Apply any required adjustments before extensive disposition.

Integration with Existing Systems:

  • Perform collaboration between IT teams, supply chain professionals, and technology vendors to apply the required integration and ensure uniform integration and data interoperability.

Training and Change Management:

  • Conduct the required and suitable training programs to develop and upgrade the awareness of the supply chain personnel with the new technologies and processes.
  • Implement Change management strategies to facilitate the adoption of new tools and workflows and apply the required strategy to overcome people's resistance to change.

Challenges Faced During Integration:

Data Security and Privacy: Dealing with sensitive information such as patient data and intellectual property may raise a concern for data security and privacy.

  • Apply the required measures to ensure compliance with data protection regulations and implement robust security measures.

Legacy Systems Compatibility: challenges occur during the application of system compatibility between new technologies and legacy systems during integration.

  • Apply all required updates or modifications to existing systems or the adoption of middleware solutions to facilitate data exchange and interoperability.

Cost and ROI Considerations:

  • There are direct costs during implementing advanced technologies in the pharmaceutical supply chain via investment in hardware, software, infrastructure, and training.
  • Do the required actions to ensure the buy-in is granted from the stakeholders while calculating the return on investment (ROI) and demonstrating perceptible benefits in terms of operational efficiency and cost savings.

Resistance to Change:

  • Addressing employees’ resistance to change is a major concern and should be settled via delivery of the correct and adequate training and support and showing them the benefits of new technologies to overcome this resistance and drive adoption.

Positive Impact on Operational Efficiency:

  • Enhanced Visibility and Traceability:
  • Via application of advanced technologies such as blockchain and IoT we can have real-time tracking and traceability of pharmaceutical products throughout the supply chain.
  • Advanced technologies improve visibility into inventory levels, shipment status, and product authenticity.
  • Via advanced technology applications, we can make more informed decision-making and reduced the risk of counterfeiting or diversion/ alteration.

Improved Forecasting Accuracy:

  • We can perform quick, accurate, precise analysis of vast amounts of data and generate more accurate demand forecasts for pharmaceutical products via the functioning of AI and machine learning algorithms which help us to have better inventory management, reduced stockouts, and improved customer service levels while minimizing excess inventory holding costs.

Streamlined Processes:

  • To focus on strategic activities, we need to enable the usage of  Robotic process automation (RPA) in doing repetitive tasks such as order processing, invoicing, and inventory reconciliation, freeing up valuable time for supply chain professionals to increase productivity, reducing manual errors, and granted efficient operations.

Faster Response to Supply Chain Disruptions/Disturbances:

  • We can adapt the application of advanced technologies to provide us with real-time insights during supply chain operations that allow faster identification and response to disruptions/disturbances such as supplier delays/interruptions, transportation bottlenecks/blockages, and/or regulatory changes.
  • The initiative-taking risk management enables us to minimize the impact of disruptions on operational efficiency.
5. Describe a time when you navigated a challenging situation with a key global supplier. How did you ensure a positive resolution while maintaining a strong and sustainable relationship?

Quality Issue with a Key API Supplier

Situation: One of our key global suppliers, responsible for providing a critical active pharmaceutical ingredient (API), experienced a quality issue that led to a temporary halt in production. This posed a significant risk to the continuity of the supply of the product to the patients.

Navigating the Challenging Situation:

Immediate Communication: Upon getting the API quality issue, I do the following:

  • Stop the production line,
  • Initiate immediate deviation report,
  • Start line communication with the supplier to understand the nature and extent of the problem.

Collaborative Problem-Solving: I do the following:

  • Arrange a cross-functional team consisting of QA, RA, production, and procurement experts to collaboratively address the quality issue with the supplier.
  • Conduct a thorough investigation to identify the root cause of the problem and develop corrective action plans.

Risk Mitigation Measures:

  • Implement risk mitigation measures to ensure continuity of  production to grant the following the supply of medication
  • Do the required action to source API from an alternative approved/qualified supplier.
  • Ensure and utilize the API strategic inventory buffer.

Supplier Support and Collaboration:

  • Maintain and keep a supportive and collaborative approach with the supplier.
  • We and the supplier emphasis our shared commitment to patient safety and product quality.
  • Support the supplier with all required technical assistance and resources to implement corrective actions and improve their QMS.

Continuous Monitoring and Improvement:

  • Implement vigorous monitoring mechanisms to track the progress of corrective actions and ensure compliance with quality standards.
  • Conduct regular follow-up meetings with the supplier to review progress, address any challenges, and identify opportunities for continuous improvement.

Positive Resolution and Relationship Maintenance:

Timely Resolution:

  • Support the supplier via collaborative efforts and effective problem-solving to resolve the quality issue within a reasonable timeframe.
  • Ensure the timely resumption of production and minimize interruptions to the supply chain.

Strong and Sustainable Relationship:

  • Implementing the required collaborative approach and commitment to address the issue with the supplier led to strengthening our relationship.
  • Promote positive and sustainable relationships built on trust and mutual respect with the supplier by showing our empathy, support, and a shared commitment to quality.

Lessons Learned and Continuous Improvement:

  • Keep Continuous improving of our QMS using our experiences and knowledge leading to improvements in quality management processes, communication protocols, and risk mitigation strategies with Supplier QMS that lead to enhance the resilience and reliability of our supply chain partnership.
6. How do you ensure global supply chain operations comply with diverse regulations? Provide an example of adapting to a significant regulatory change that impacted the supply chain.

How compliance can be ensured, along with an example of adapting to a significant regulatory change:

Regulatory Monitoring and Awareness:

  • Determine a regulatory monitoring system to enhance and be aware of the following:
  • Stay informed about changes in regulations related to trade, customs, transportation, product safety, environmental standards, and other relevant areas in different regions where the company operates.

Cross-Functional Collaboration:

  • Ensure a comprehensive understanding of regulatory requirements and their implications for supply chain operations.
  • Adopt collaboration between supply chains, legal, regulatory affairs, and compliance teams.

Supplier Compliance Assessment:

  • Assess the compliance of suppliers and partners with applicable regulations.
  • Perform and conduct the required vendor audits, verifying certifications, and ensuring adherence to ethical and environmental standards.

Documentation and Record-Keeping:

  • Demonstrate compliance with regulatory requirements via maintaining accurate documentation and records including import/export documentation, product certifications, and materials safety data sheets “MSDS,” and other relevant documents.

Training and Education:

  • Ensure breeding the culture of compliance in the supply chain via performing regular training and education to supply chain personnel and partners on regulatory requirements, compliance procedures, and best practices.

Adapting to Regulatory Changes:

  • Adapt quickly to regulatory changes that impact supply chain operations via developing contingency plans and agile response mechanisms.
  • Apply the required modifying sourcing strategies, adjusting transportation routes, updating documentation, or revising processes to ensure compliance.

Example of Adapting to a Significant Regulatory Change:  

“A global pharmaceutical company had to adapt to a significant regulatory change related to product serialization requirements in a key market.”

  • Regulatory Change: issuance of new regulations requiring pharmaceutical companies to serialize individual units of prescription medications to enhance traceability and combat counterfeit drugs.
  • The change mandated the inclusion of unique identifiers, such as serial numbers and barcodes, on packaging for all prescription medications sold in the market.

Adaptation Strategy:

Regulatory Assessment:

  • Conduct a thorough assessment of the new regulations to understand their scope, timelines, and implications for supply chain operations via the company team “QA, Supply chain, and RA”.

Collaboration with Suppliers:

  • Perform the required collaboration with the packaging suppliers to implement serialization solutions compliant with the new regulatory requirements.
  • Perform the required changes in the packaging line to adapt the required integrating serialization equipment.
  • Perform the required verification and validating serialization processes to ensure accuracy and reliability.

Internal Process Updates:

  • Update internal processes and systems to incorporate serialization data into inventory management, distribution, and reporting systems.
  • Perform the required modification at warehouse management systems (WMS), enterprise resource planning (ERP) systems, and electronic data interchange (EDI) protocols to capture and track serialization data throughout the supply chain.

Training and Education:

  • Develop and implement comprehensive training programs to educate supply chain personnel about the new serialization requirements, proper handling of serialized products, and the importance of compliance.

Continuous Monitoring and Compliance:

  • Establish mechanisms for ongoing monitoring and compliance verification to ensure adherence to serialization requirements throughout the supply chain.
  • Perform regular audits, quality checks, and validation processes were conducted to maintain compliance and address any issues promptly.

Via proactively adapting to the significant regulatory change through collaboration, process updates, training, and compliance monitoring, the pharmaceutical company ensured seamless integration of serialization requirements into its global supply chain operations while maintaining compliance with regulatory standards.

7. Share an experience where data analytics played a pivotal role in a strategic decision-making process within the global supply chain, leading to improved efficiency or cost savings.

How data analytics played a pivotal role in a strategic decision-making process within the global supply chain, leading to improved efficiency and cost savings  

Scenario: Demand Forecasting and Inventory Optimization

Situation: As the technical quality director for a global pharmaceutical company, I faced challenges in collaboration with the supply chain manager in inventory management and demand forecasting for critical medications.

Demand market fluctuations, changing market dynamics, and regulatory requirements changes/updates dramatically made it challenging to maintain optimal inventory levels while ensuring product availability and minimizing excess inventory costs.

Utilizing Data Analytics:

  • Data Collection: perform trend analysis for the historical sales data, market trends, customer demographics, and product lifecycle information to build a comprehensive dataset for demand forecasting and inventory optimization.
  • Predictive Analytics: perform historical data analysis to identify demand patterns, seasonality, and trends, enabling more accurate demand forecasts via using advanced data analytics techniques such as predictive modeling and machine learning algorithms.
  • Demand Segmentation: perform market and customer segmentation using various factors such as geography, customer segments, product categories, and sales channels to capture variations in demand behavior and tailor inventory strategies.

Inventory Optimization:

  • Use data analytics to optimize inventory levels by identifying the optimal balance between stock availability, service levels, and inventory costs.
  • Set and identify the safety stock levels, reorder points, and lead times based on demand variability and supply chain constraints.
  • Analyze to simulate different demand scenarios, supply chain disruptions, and inventory strategies to assess their impact on service levels, inventory costs, and overall supply chain performance.

Positive Impact on Efficiency and Cost Savings:

  • Effectively leveraging data not only involves collecting and analyzing data points, but it also requires companies to act on the insights from that data.
  • Improved Forecast Accuracy: perform accurate analysis of data from a variety of sources to measure performance and process, set strategic goals, and guide improvement.
  • Determine the demand forecasting.
  • Implement significant improvements in forecast accuracy, reducing forecast errors and enabling better alignment between inventory levels and customer demand.
  • Optimized Inventory Management: improve working capital efficiency and reduce carrying costs by using data-driven inventory optimization strategies to reduce excess inventory holding costs while ensuring product availability and minimizing stockouts.
  • Enhanced Supply Chain Agility:  fast response to changing market conditions and reducing the risk of obsolescence via showing the ability to foresee demand fluctuations and proactively adjust inventory levels improved supply chain agility, enabling faster response to changing market conditions and reducing the risk of obsolescence.
  • Cost Savings: implement data-driven inventory optimization strategies including reduced inventory carrying costs, lower transportation costs, and improved operational efficiency.

The strategic utilization of data analytics in demand forecasting and inventory optimization played a pivotal role in improving efficiency and cost savings within the global supply chain of the pharmaceutical company.

8. Discuss a specific initiative you implemented to promote sustainability in the global supply chain. What measurable impact did it have on reducing the environmental footprint?
  • How I implemented specific initiatives to promote sustainability in the global supply chain
  • How we can measure its measurable impact on reducing the environmental footprint:

Our initiative is hot to make our Packaging materials Sustainable.

Objective: packaging materials environmental impact reduction via the supply chain, in parallel, with maintaining the product quality and making the most cost-effective process.

Implementation methodology:

1. Evaluation/assessment of the Packaging Material:

  • Perform a deep and complete assessment of packaging materials used within the supply chain such as primary, secondary, and tertiary packaging.
  • Identification of the optimization opportunities.

2. Green Material Selection:

  • Using lower environmental footprints packaging materials such as: recycled, biodegradable, and carbon emissions materials during manufacturing processes.

3. Optimizing packaging materials design:

  • While making the design, we tried to minimize material usage, enhance space during transportation, and boost recyclability/composability after usage.

4. Cooperation with suppliers

  • Perform close cooperation with our packaging materials suppliers to provide us with green materials, and foster advanced packaging solutions, while maintaining quality, safety, and regulatory legislation compliance.

5. Packaging materials Testing and Evaluation:

  • Perform direct testing for the received packaging materials to evaluate their performance in terms of product protection, transportation efficiency, and environmental impact.

6. Stakeholder Commitment:

  • Enhance the participation and commitment of internal stakeholders such as the design team, purchasing/planning personnel, warehousing staff, research and development team, and Quality staff for the reason of delivering awareness and encouraging orientation with company sustainability goals.

Measurable Impact:

Cut down Material Usage:

  • Achieve a remarkable reduction in packing materials usage within supply chain processes.

Decrease Carbon Footprint:

  • Via using recycled materials and/or materials with lower carbon emissions within our production processes, we can reduce contributed carbon emissions and achieve a remarkable reduction in environmental footprint during packaging and disposal processes.

Improve delivery and transportation Ability:

  • Decrease the number of shipments via good use of container space, which resulted in lowering the fuel consumption and greenhouse gas emissions associated with transportation processes.

Waste Reduction: using recycled/ compostable Packaging materials enhances the proper disposal after usage, decreases waste, and reduces the cost of disposal.

Via performing packaging materials Optimization towards sustainability, we achieve a remarkable cost, reduction, carbon footprint, and GHG emission, and propose stakeholder involvement and commitment.

9. Can you provide an example of a successful collaboration between different departments to resolve a complex issue within the global supply chain? Emphasize the importance of cross-functional teamwork.

Good collaboration among all relevant divisions and department staff is the basis for resolving complex issues within the global supply chain problems and overcoming its challenges.

Scenario: Shortage of Critical Raw Material

Issue: we faced a shortage of raw materials, which affected the smooth running of production processes resulted in delays in the production schedule, and affected the finished products' delivery to the market.

Steps to overcome this critical problem:

1. Perform Supply Chain Management:

a. Control/monitor warehouse inventory level in time and assess supplier performance in advance and continually to avoid sudden shortages.

b.Continually assess the shortage impact on production schedules, inventory levels, and customer demand.

c. Seek alternative suppliers for the shortage of materials.

d. Guarantee the presence of three suppliers for all materials required and agree with them on a convenient sourcing approach depending on their capability and conformance to regulatory legislation.

2. Research and Development (R&D) role:

a. Save all resources to our R&D teams to prepare more than one product formula regarding ingredients alternatives, especially the critical one.

b. Ensure compliance via compatibility testing for alternative product formulas to ensure their safety and efficacy.

3. Regulatory Affairs role:

a. Assure getting the authority approval via RA staff for alternative suppliers’ ingredients as required.

b. Submit product e-submissions for authority approval for all product formulas in time and as required.

4. Quality division role [QA/QA]:

a. Assess and inspect suppliers for regulatory conformance and QMS in place.

b. Work closely with QA and QC teams to ensure changes in supplier and/or product formula conform to quality standards and regulatory requirements.

c. Perform regular and continual monitoring of the quality system via conducting risk assessments and implementing the required QC measures to ensure the products are produced consistently.

Results and Impact:

Timely Resolution: Team collaboration ensures resolving the shortage of critical materials in a short time and reduces the interruption of the production schedule/plan.

Via teamwork and its initiative-taking approach, we granted continuity of product delivery to the market actively.

Save critical material alternative supplier: identification of the qualified/certified suppliers for critical materials is a crucial role of the SC team to avoid sudden and/or unplanned material shortages.

R&D alternative formula adjustments: developing alternative product formulas is a successful pathway to guarantee production running in case of a shortage of critical material provided that all product formulas come in compliance with product specification, and regulatory requirements.

Patient Effect: saving critical and life-saving products for patients in time and ensuring their continued availability in the market is the global goal of the pharmaceutical industry which is achieved via cross-functional teamwork within the global supply chain logistics.

10. Describe a situation where you identified a bottleneck or inefficiency in the global supply chain and led a successful initiative to drive continuous improvement, resulting in enhanced performance.

Where and how we can identify a bottleneck in the global supply chain within the pharmaceutical industry and lead a successful initiative to drive continuous improvement, resulting in enhanced performance:

Scenario: Purchasing Process Bottleneck

The approval process for the new supplier is a bottleneck, especially in the case of critical starting materials.

The long pathway of the supplier approval process and its approval from the relevant authority led to delays in the purchasing process, consequently, affecting the production schedule.

Identification of Bottleneck:

Purchasing process analysis: identify the inefficiency in the procurement process by analyzing the lead time including supplier approval/qualification timelines, and on-time delivery.

Stakeholder Feedback: collect feedback from relevant stakeholders such as the supply chain team, and planning management team including the production planning responsible,  to oversee and determine the obstacles and challenges within the supplier approval/qualification process.

Process Mapping: map the process from start to end, starting with the supplier under evaluation process, supplier approval, supplier qualification, supplier certification, relevant authority approval on the selected supplier, contract agreement, etc., and identify the bottlenecks, unnecessary steps, and improvement areas.

Continuous Improvement Initiatives:

Enhancing Supplier Evaluation:

i. Establish clear supplier approval criteria considering the relevant legislation, assessment formats, and risk assessment methodology.

ii. QA staff shall cooperate with RA staff, and SC staff to have a clear view and agreement on the required quality parameters and compliance requirements.

Documentation Requirements:  improve the documentation requirements for supplier approval/qualification in collaboration between cross-functional teams including QA, QC, SC, production, and R&D teams, ensuring compliance with relevant regulatory requirements.

Automation and Digitization:

i. Use digital tools and automation technologies to rationalize procurement workflows, improve data visibility, and enhance/speed up the supplier approval/qualification process.

ii. Use EDMS “electronic document management systems” and supplier portals “if available” for smoothing the communication and document exchange.

SRM “Supplier Relationship Management”:

i. Initiative-taking   SRM fosters cooperation transparency, and continuous improvement.

ii. Perform regular inspection/evaluation for supplier performance, enhance supplier development process, and make alliances with suppliers for strategic partnerships aiming to drive mutual recognition and value improvement.

Results and Impact:

Lead Times reduction: enhancing the supplier approval/qualification process led to reducing the supplier contracting process lead times, enabling constant purchasing process of the critical raw materials and better-quality response to demands change.

Enhanced Operational Efficiency: using automation and digitization improves operational efficiency, reduces operating expenses, and improves data visibility, enabling better decision-making and resource allocation.

Enhanced Supplier Collaboration: The focus on supplier relationship management and collaboration fostered stronger partnerships with key suppliers, leading to improved communication, quality performance, and supply chain resilience.

Cost Savings: improved supplier collaboration resulted in cost savings via enhanced inventory management, reduced lead times, and better negotiation outcomes with suppliers.

11. Given the increasing unpredictability in global markets, how have you proactively built resilience into the supply chain? Share an experience where this resilience was put to the test and proved effective in overcoming a disruption.

Building resilience in the supply chain in the pharmaceutical industry is crucial, especially in the face of increasing unpredictability in global markets.

 Initiative-taking Resilience-Building Measures:

Suppliers’ segmentation: I perform supplier segmentation based on the delivery of critical raw materials and active pharmaceutical ingredients (APIs) to reduce dependence on single-source suppliers and control the risk of supply disturbances.

Build dual Sourcing Strategy: build a dual sourcing strategy for key components and materials, and start sourcing from multiple suppliers or regions to ensure continuity of supply in case of disturbances.

Inventory Buffer:  maintain strategic inventory buffers for critical raw materials and finished products to mitigate against sudden demand variations, supply disturbances, or transportation delays.

Risk Assessment and Mitigation:

i. Perform deep and collective risk assessments to identify potential weaknesses in the supply chain, including geopolitical risks, regulatory changes, natural disasters, and transportation disruptions.

ii. Develop risk mitigation plans to address identified risks and enhance supply chain resilience.

Collaboration with Logistics Partners: create close collaboration with logistics partners to utilize contingency plans and alternative transportation routes to mitigate the impact of transportation disturbances, customs delays, and port closings.

Experience of Overcoming Disruption:

Scenario: Disruption in Supply of Critical Raw Material

During a global health crisis such as the coronavirus, we face lots of disturbances for many of our approved suppliers, especially for Critical APIs used in the production of important products due to lockdown measures, transportation restrictions, and labor shortages in the supplier's region. This interruption threatens the availability of the drugs for patients.

Response and Effectiveness of Resilience Measures:

Rapid Response: engaged alternative suppliers in fast response to satisfy the shortage of critical APIs from the other supplier.

Accelerate Transportation: work on a win-win approach with our logistics partners to ship the critical APIs using alternative available routes and prioritize shipments to ensure timely delivery to our port, consequently, we deliver them to our manufacturing facility.

Inventory Buffer Utilization: change the production plan to continue production with alternative products and/or use alternative suppliers for the critical APIs.

Continuous Communication: keep and maintain open communication channels with internal stakeholders, including production teams, SC team, and main distributors, and keep them updated with the situation.

Outcome:

Using initiative-taking resilience-building measures and effective response strategies, the supply chain successfully overcame the disturbance in the supply of critical raw materials.

12. As we conclude, what specific skills or experiences uniquely qualify you for addressing the challenges in global supply chain logistics? How do you envision leveraging these strengths to contribute to the success of our organization's supply chain strategy?

I would like to highlight specific skills and experiences that uniquely qualify me for addressing the challenges in global supply chain logistics, and how I envision leveraging these strengths to contribute to the success of our organization's supply chain strategy:

Full Understanding of Supply Chain Dynamics:

With my extensive background and experience in managing global supply chain logistics, I attain a deep and thorough understanding of the complications, interdependencies, and best practices within the supply chain ecosystem. Such as expertise in 

  • inventory management
  • demand forecasting,
  • supplier relationship management,
  • transportation logistics, and
  • risk mitigation strategies.

Data-Driven Decision-Making:

Via my longer years of experience in the same industry with a variety of fields, I used my expertise in data analytics and advanced technology to drive strategic decision-making in the supply chain.

 By harnessing data analytics tools and predictive modeling techniques, I can identify trends, anticipate demand fluctuations, optimize inventory levels, and improve operational efficiency, thereby enhancing the overall performance of the supply chain.

Cross-Functional Collaboration:

I excel in development collaboration and alignment across diverse functional teams, including SC team, production, quality assurance, and regulatory affairs.

 My ability to effectively communicate, negotiate, and influence stakeholders enables me to build strong partnerships and drive cross-functional initiatives to address complex supply chain challenges.

Resilience and Adaptability:

In the face of evolving market dynamics, geopolitical risks, and unforeseen disruptions, I possess the resilience and adaptability to navigate uncertainty and implement active response strategies.

My experience in proactively building resilience into the supply chain, including supplier segmentations, risk mitigation plans implementation, and maintaining strategic inventory buffers, make me ready to effectively manage supply chain disturbances and ensure business continuity.

Strategic Vision and Continuous Improvement:

I consider and advocate to say that I am committed to driving continual improvement and innovation within the supply chain by fostering a culture of excellence, learning, and adaptation.

With a strategic mindset and a focus on long-term sustainability, I can start implementing initiatives to optimize processes, reduce costs, enhance efficiency, and mitigate risks, in that way contributing to the success and competitiveness of our organization's supply chain strategy.