Job Description

General Summary:

The Director, Manufacturing Technical Services, Quality Assurace is responsible for the quality oversight of Contract Manufacturing Organizations (CMOs) and Contract Test Labs (CTOs) for Cell & Genetic Programs through the lifecycle development process. This includes quality oversight for the selection, qualification and routine monitoring of Contract manufacturers and laboratories. The role will assure Quality oversight for technical and operational CDMO activities from clinical throughout product commercialization activities, post-approval process monitoring and change management. The role is also responsible for the development and maintenance of relationships with the external 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 Virtual Product Team.

Key Duties and Responsibilities:

• Be the Quality expert for both US and European CMOs and CTOs.
• Build strategic relationships with CMOs and CTOs within the Quality organization and participates in Business Review Meetings to ensure Quality issues are raised and addressed, as necessary.
• Leads from a Quality perspective root cause analysis and product impact assessments for investigations resulting from deviations at the CMOs and CTOs.
• Negotiate, monitor and maintain Quality Agreements with CMOs.
• Lead/Support/Execute Quality oversight for clinical and product commercialization activities.
• Lead quality process monitoring of the CDMO
• Execute change management and vendor notifications as part of product life cycle management.
• Liaises with cross-functional teams for external quality commercial operations in support of GMP manufacturing and testing activities, including disposition
• Leads/executes continuous improvement activities and drive quality remediation .
• Work closely with the Audit and Inspection Quality Function to establish the audit strategy for Auditing and Performance oversight and support technical site audits including preparation for regulatory inspections.
• Establishment of vendor quality oversight processes including qualification, risk categorization and routine monitoring.
• Provide guidance and support through Quality representation in relevant geographies at periodic intervals on site at the CDMOs.
• Participate in Cell & Genetic Program and Quality projects.

Knowledge and 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 (e.g., QDoccs, Trackwise, Veeva)
• 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 drivers;
• Critical Thinking and Problem Solving skills
• Strong leadership and an innate ability to collaborate and build relationships.

Education and Experience:

• Bachelor's degree in a scientific or allied health field (or equivalent degree)
• Typically requires 10 years of work experience and 2 years of management experience, or the equivalent combination of education and experience

Hybrid-Eligible Roles

In this Hybrid-Eligible role, you can choose to be designated as:

Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.

#LI-Hybrid #LI-ND2

Company Information