Director, Manufacturing Technical Services, Quality Assurance Cell and Gene (Hybrid)
Vertex Pharmaceuticals
- Boston, MA
- Permanent
- Full-time
- 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.
- 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.
- 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