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Bristol Myers Squibb

Senior Manager - QA Operations

Bristol Myers Squibb

Indianapolis, IN · full time · Senior

$141,515 – $171,483

Listed on Bristol Myers Squibb’s own careers site. You apply with them directly — we never stand between you and the employer.

What this role is

This senior operations quality assurance role oversees compliance and quality activities across manufacturing and supply chain functions at a radiopharmaceutical manufacturing site, managing up to 8 staff members. The position suits experienced quality professionals with deep FDA/EMA regulatory knowledge and hands-on shop-floor expertise who can lead teams through complex manufacturing challenges in a fast-paced biotech environment.

Our summary, not Bristol Myers Squibb’s wording. The full posting is on their site.

Skills this role names

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What they ask for

Required

  • 10+ years cGMP experience
  • 5+ years QA shop floor or operations experience
  • FDA/EMA regulatory knowledge in biopharmaceuticals or radiopharmaceutical manufacturing
  • Experience with quality management systems for change control, deviations, investigations, and CAPA
  • Leadership of on-site quality operations teams
  • Ability to work in cleanroom environments and handle radioactive materials
  • Bachelor's degree in STEM field or high school diploma/Associates degree with equivalent work experience

Nice to have

  • Experience in aseptic/sterile environments or quality control operations with microbial controls
  • Cell/gene therapy manufacturing experience
  • Experience with electronic batch record systems, ERP systems like SAP, or quality management platforms like TrackWise or Veeva

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