Job Overview:
The Associate Director Quality Assurance, Drug Substance role involves leading the QA Operations team for onsite quality monitoring of drug substance manufacturing. The successful candidate will be responsible for supporting technology transfer, shake down batches, and site GMP readiness initiatives.
Main Responsibilities:
* Lead QA operations team for onsite quality monitoring of DS manufacturing.
* Support inspections and self-audits, providing coaching and guidance to the team.
Requirements:
* Degree in biopharmaceutical science or a related discipline.
* Minimum 8 years experience in vaccine or biopharma DS manufacturing, with sterile filling experience highly desirable.
* Proven track record in managing a team, mentoring specialists, and driving operational excellence.
Key Qualifications:
* Strong knowledge of European regulations, cGMP, and quality compliance standards.
* Excellent interpersonal and communication skills, able to work collaboratively in a matrix environment.
* Ability to adapt in a fast-changing environment, balancing compliance with operational demands.