Our client is seeking a Contract Quality Assurance Manager near Boston, MA!
Our client is an integrated global leader in pharmaceutical synthesis & specialty ingredients, delivering outstanding performance, unrivaled market responsiveness, and tailored-made solutions to its customers. The company offers their customers custom-development small-molecule active pharmaceutical ingredients as well as in vitro diagnostic services. They are a mid-sized company that is experiencing growth, offering potential for upward-mobility in the future.
- Proactively perform Quality Assurance functions in full compliance with current Good Manufacturing Practices (cGMP)
- Manage team of Quality Assurance Specialists for daily planning, maintenance, and operation of the company’s quality systems, including but not limited to:
- Batch Record Review & Release
- Quality Investigations (including Deviation Control), material control, and change controls
- Corrective Action / Preventative Action (including effectiveness) and customer complaints.
- Manage team of Document Specialists operating the site’s document control system, including:
- Documentation review/approval and document change control
- Record Retention of Quality Records (Archival and retrieval)
- Contribute to the Supplier Qualification program, including documentation, correspondence and external auditing required for vendor approval and ongoing compliance.
- Contribute to the internal audit program to ensure continued compliance to the Quality Program and cGMP
- Maintain system for monitoring of Quality Metrics for reporting (Local Management and Corporate)
- Contribute and provide oversight to Management Quality Review (QMR) Program
- Bachelor’s degree in a related field of science, or equivalent formal training and experience
- 10+ years working in a Quality Manager role under cGMP
- Thorough knowledge of GMP principles, specifically 21 CFR 211 and ICH Q7
- Experience with electronic Quality Management Systems
- Understanding of EMA Quality standards and principles (preferred)