Start Date
Immediate
Expiry Date
11 Aug, 25
Salary
0.0
Posted On
11 May, 25
Experience
0 year(s) or above
Remote Job
Yes
Telecommute
Yes
Sponsor Visa
No
Skills
Timelines, Deviations, Strategy, Gene Therapy, Root, Communication Skills, Data Analytics, Manufacturing, Dmaic, Six Sigma, Product Life Cycle, Root Cause Analysis, Testing, Commercials, Finish
Industry
Pharmaceuticals
GENERAL SUMMARY:
The Associate Director, Manufacturing Technical Services, Quality Assurance is responsible for supporting the day-to-day Quality Operations of Contract Manufacturing Organizations (CMOs) for Cell & Genetic Programs through the management of quality management system (QMS) events. The role will assure Quality oversight for technical and operational CDMO activities from clinical throughout product commercialization activities, post-approval process monitoring and deviation management. This is the lead role that will drive comprehensive QMS monitoring and tracking for dedicated CDMO(s).
The role is 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 QMS. The successful candidate will be a key member of the Vertex Cell & Genetic Therapy Quality Team and the Virtual Product Team.
KNOWLEDGE AND SKILLS:
EDUCATION AND EXPERIENCE: