External Quality Operations Manager (GMP)

Added
12 hours ago
Type
Full time
Salary
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Related skills

audits gmp cmos capa cgmp

πŸ“‹ Description

  • Act as EQOM; single point of contact for quality activities at CMOs.
  • Ensure GMP/GDP compliance; uphold QTA and Sobi quality standards.
  • Bridge Sobi with external partners; drive compliance and continuous improvement.
  • Collaborate across Manufacturing, Supply Chain, and Regulatory Affairs.
  • Support batch release and data reviews (APQR/PQRs) per QTA and CGMP.

🎯 Requirements

  • University degree in pharmaceutical, biotech or life science.
  • 5+ years in pharma/biotech QA with GMP/GDP experience.
  • 1+ year managing external quality oversight of CMOs.
  • Fluent in English (spoken and written).
  • 2+ years in global operations with English as main language.
  • Proven track record leading Quality KPI at CMOs; FDA/EMEA exposure.

🎁 Benefits

  • Competitive benefits package.
  • Generous time off policy.
  • Opportunity to attend conferences.
  • Work-life balance culture.
  • Collaborative, team-oriented environment.
  • Meaningful impact for rare disease patients.
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