Sr Manager GMP QA - Contract - Boston, MA
Ensuring compliant product release while strengthening quality systems across the manufacturing lifecycle.
Proclinical is seeking a Sr Manager GMP QA to support batch disposition and core GMP Quality Management System (QMS) activities. This position requires hands‑on experience in GMP Quality within a pharmaceutical manufacturing environment. Familiarity with small‑molecule drug substances and oral solid dosage forms, such as capsules and tablets, is highly valued.
Primary Responsibilities
The successful candidate will contribute to day‑to‑day GMP Quality operations, including batch record review and release, deviation management, change control, product complaints, and other quality processes.
Skills & Requirements
- Hands‑on experience in GMP Quality Operations, with a strong background in batch disposition and QMS processes.
- Proficiency in managing deviations, change control, CAPAs, and product complaints.
- Experience with small‑molecule drug substances and oral solid dosage forms (e.g., capsules, tablets) is strongly preferred.
- Ability to work independently and provide proactive Quality support in a fast‑paced environment.
- Familiarity with Veeva Docs/QMS systems is a plus.
The Sr Manager GMP QA's responsibilities will be:
- Oversee GMP Quality batch disposition activities, including batch record review and release readiness.
- Manage or support deviations, investigations, CAPAs, change controls, and product complaints.
- Collaborate with internal teams and external manufacturing partners to ensure GMP compliance.
- Provide Quality oversight for manufacturing and supply‑related activities.
- Support continuous improvement initiatives and ensure adherence to GMP regulations and internal QMS procedures.