Title: Sr. Manager/Manager, Compliance
Location: Billerica, MA
A global leader in pharmaceuticals is seeking a qualified candidate to join the QA Compliance team. This Manager or Sr. Manager, Compliance will be responsible for developing, establishing, and maintaining Quality Systems, policies, processes, and controls, and ensuring that QA Documentation meet compliance standards.
- Provide QA review of Annual Product Reviews (APR), recommend CAPA as needed
- Issuance of Quality Alerts, Field Alert Reports (FAR), an Recalls
- Implement electronic Quality Systems (eQMS, EDMS, LMS, etc.), provide guidance and training to employees
- Lead Monthly Quality Investigation Board (QIB) and Quality Review Board (QRB)
- Supervise QA documentation department
- Assist with FDA and compliance audits, prepare annual internal audit schedule
- 10 years related experience (pharma, biotech, QA/QC, or FDA regulated industry)
- Strong QMS knowledge
- Knowledge of 21 CFR parts 210, 211
- Aseptic drug manufacturing experience preferred
- Must be authorized to work in the US.
If this sounds like the right opportunity for you, please apply!