Associate Director, Operational Area Quality, Materials Management (Hybrid)

Job Description

The Associate Director in Materials Management is responsible for quality oversight of all materials used in drug product manufacturing, and associated materials management controls to meet cGMP requirements. This includes providing quality oversight to inventory management, and consumption controls to assure accurate lot genealogy and traceability throughout the drug product manufacture.

The role is also responsible for the development and maintenance of relationships with the external material and manufacturing vendors, to drive compliance, monitor performance and support continuous improvement activities. 

The quality role will closely partner with operational stakeholders and participate in associated governance for the successful planning and execution of the product life cycle Management.  The successful candidate will be a key member of the Vertex Cell & Genetic Therapy Quality Team and the Operational Product Teams.

Key Duties & Responsibilities

• Be the Quality expert for all regions on material management.
• Partner with material vendors and CDMOs within the Quality organization and participate in Business/Quality Review Meetings to ensure Quality issues are raised and addressed, as necessary
• Oversight of  material management program and systems across CDMOs and Component manufacturers network
  • Assure processes are compliant for the release and usage of all materials including critical components at the CDMOS to assure lot genealogy and traceability of materials in drug product manufacture.
• Lead quality process monitoring of the drug product materials through establishment of proactive monitoring and indicators for compliance oversight
• Report on CDMO/vendor performance metrics at Quality/Governance meetings.
• Partner with CMSC to provide Quality oversight for evaluating, implementing and maintaining systems including performance monitoring to optimize the procurement and maintenance of all product materials.
• Liaise with material suppliers to identify Quality / compliance issues and partner with them to align on the risk and mitigation plans.
• Negotiate and maintain Quality Agreements with clear and tangible metrics with Vertex owned material suppliers. 
• Assess critical components / raw materials traceability across the CDMOs network for effective lot genealogy.  Work with CDMOs to Identify and execute mitigation plans to close gaps.
• Participate in mock lots’ traceability sessions with the component suppliers and CDMOs.
• Act as the Quality SME for root-cause analysis and material impact assessments for investigations resulting from deviations at the CDMOs. 
• Act as the Quality SME for any corrective actions identified from investigations to implement viable, permanent solutions to materials related issues. Work with both internal and external customers to develop solutions which meet company-wide needs and objectives.
• Establish oversight and consistency on Bill of Materials across the network.
• Risk Management:
  • Identifying and mitigating gaps and risks associated with the material management program
  • Ensure the risk register is kept updated and communicated across Quality teams and other stakeholders.
• Continuous Monitoring:
  • Stay up to date with industry developments and best practices to guide business partners and assure the Materials Management Quality oversight program remains compliant and effective.
• Training and Development:
  • Providing training and guidance to materials management staff on quality assurance procedures

Required Knowledge/Skills

• In-depth global regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics.
• Experience in product life cycle from discovery to commercials product development
• Broad understanding of regulatory environment including quality systems, compliance and strategy.
• Broad technical knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.
• Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
• Substantial experience with electronic document management systems
• Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
• Ability to apply risk management principles to decision making and operational priorities.
• Substantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business