We have partnered with a rapidly growing Biotech to find their next Sr. Quality Compliance Manager for their Cambridge location. You will be trusted to ensure proper Quality Management Systems are implemented and documented throughout all phases of drug development as well as internal and external audits. If you have a proven track record of working in a supervisory or management role and are ready to take your career to the next level - keep reading!
Responsibilities:
- Internal and external GMP/GDP audits from scheduling to following up, escalating observations when needed
- Work cross-functionally to accomplish company and individual team's goals
- Assist with inspection readiness
- Help develop, maintain, and execute annual audit plans
- Monitor industry and company trends on how they may impact their organization
- Complete vendor audits
Preferred Experience:
- Bachelor's Degree in a scientific discipline
- 6+ years of quality experience in the Pharmaceutical space
- Solid knowledge of GMP, GDP, and GCP regulations
- 2-4 years of supervisor or management experience
- Strong technical report writing skills
- Previous experience with hosting regulatory inspections in support of clinical research and/or related processes
