CQV Supervisor
About the role
This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This role will require CQV experience, represent CQV work in the regulator and internal audits, ability to work independently, drive effectivencommunication, coordination and collaboration across relevant cross functional groups to establish a strong, compliant CQV program to enable robust production, testing and release of product to patients.
Responsibilities
- Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant.
- Manages multiple and complex CQV projects, collaboration with cross functional teams, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks.
- Supports and/or owns technical and quality investigations, CAPAs and corrections
- Develops and performs any required remediation efforts and associated CAPA plans.
- Authors, owns and