Quality Manager V

Description

We're looking for a Quality Manager V , working in the Pharmaceuticals and Medical Products industry in 225 2nd Avenue, Waltham, Massachusetts, 02451, United States .

Responsibilities:

1. Provide quality oversight of cGMP external drug substance manufacturing operations.
2. Provide quality guidance and support for investigations and change controls.
3. Provide support of process performance qualification activities including document review and approval.
4. Provide support of product stability programs including document review and approval.
5. Perform review/approval of master production records, executed batch records and disposition of product.
6. Provide quality support for clinical and commercial technology transfers to CMOs.
7. Provide support of Quality Management Systems, as needed - e.g. product quality reviews, data compilation and analysis, audits, risk program.
8. Provide PAI readiness support including on-site support of CMOs, as needed.
9. Travel, as needed to CMOs to support products.
10. Participate in routine internal and external Operations Meetings.
11. Escalate quality and compliance issues to quality management.