Title: Compliance Manager
Summary: A global leading specialty generic pharmaceutical company is currently seeking a driven and motivated Compliance Manager to lead their Massachusetts plant. You will manage the development, establishment, and maintenance of Quality Systems, policies, processes, procedures, and controls to ensure the performance and quality of cGMP documentation and records conforms to established standards. Do you want to help make a difference in improving people's lives through high-quality, affordable medicines? If yes, please reach out to learn more!
The Compliance Manager will be responsible for…
- Supervising the QA Documentation Department in the creation, issuance, maintenance, archiving, and storage of cGMP and cGXP controlled documentation and records
- Managing electronic document processing, retrieval, EDMS, LMS, and TrackWise
- Leading Monthly QRB and QIB meetings
- Providing QA review of APRs to identify trends and recommend CAPAs
- Handling PQCs and quality alerts, FAR/recall as per internal procedures
The Compliance Manager should have the following qualifications:
- Bachelor's Degree in Chemistry or related scientific field
- Minimum 10 years of experience
- Expert knowledge of QMS and adherence to 21 CFR Parts 210, 211
- Experience with electronically based Quality Systems
- Aseptic drug manufacturing experience is a plus
The firm offers benefits covering medical, dental, vision, and retirement as well as programs aimed at helping you improve your own health and well-being.
- 401k company match begins day one (100% vesting immediately)
- Telehealth and behavior health services with prescription drug coverage
- Corporate discounts on entertainment and consumer goods
If you are interested in the Compliance Manager role, then please don't wait to apply!