Quality Operations Program Manager - Document Control

Added
22 days ago
Type
Full time
Salary
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Related skills

gcp document control gmp qms capa

πŸ“‹ Description

  • Own lifecycle management of quality documents and records.
  • Administer Veeva eDMS: config, users, lifecycle, improvements.
  • Provide quality oversight on regulated activities and deliverables.
  • Offer regulatory interpretation and guidance on federal regs and quality systems.
  • Develop metrics and track effectiveness of domain systems.

🎯 Requirements

  • BS/BA in Science, Information Management, Engineering, or equivalent.
  • 5+ years in a regulated quality role in Life Sciences.
  • Experience with Quality Management Systems (docs, records, training, change control, CAPA).
  • Experience with electronic DMS (eDMS) and/or electronic QMS (eQMS).
  • Strong understanding of GxP, 21 CFR 11, ICH Q10, QSR, ISO9001.
  • Excellent process mapping, problem-solving, and communication skills.

🎁 Benefits

  • Medical, dental, vision, and basic life insurance.
  • Flexible PTO and company paid holidays.
  • Retirement programs.
  • 1% charitable giving program.
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