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Proclinical Logo Proclinical · IT - Administration

Sr Manager GMP QA

United States, Boston · Job Posted July 14, 2026
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Job Description

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.

Job Responsibility

  • 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

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

Nice to have

Familiarity with Veeva Docs/QMS systems is a plus

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