What are the responsibilities and job description for the Quality Assurance Director position at beBee Careers?
Job Overview: We are seeking a highly experienced Quality Assurance Director to oversee quality operations and ensure compliance with regulatory requirements in a multi-product cell therapy manufacturing facility.
Key Responsibilities:
- Represent Quality Assurance on the Site Leadership Team and Technical Transfer teams to onboard new clients.
- Partner with cross-functional stakeholders for continuous improvement activities, implementation of new procedures, training requirements, etc.
- Lead Quality Culture initiatives and performance.
- Host client audits and inspection preparedness activities.
- Develop and implement operational excellence tools and methodology.
- Manage the day-to-day activities of the QA Operations team to support product manufacture, testing, and release.
Requirements:
- 10 years of experience in GMP Quality in biologics industry with a minimum of 5-8 years of experience, coaching, mentoring, and supervising direct reports.
- Proficiency in use of electronic QMS Software.
- Excellent attention to detail, organizational, and time management skills.
- University degree in life sciences or related fields is required.
About Us: We are a world-leading contract development and manufacturing organization creating cutting-edge therapies that change people's lives. We value diversity and inclusion, and we believe that our diverse community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.
