Manager / Sr. Manager – Quality GMP
$115,000–$140,000 year
On-siteBasel, Basel-City, Switzerland
Job Summary
Oversee day-to-day quality interface with CDMOs producing drug substance and drug product for ongoing clinical programs. Support new vendor qualification, audits, and Quality Technical Agreements while monitoring vendor compliance and escalating risks. Review Master Batch Records, analytical methods, validation protocols, specifications, release data packages, and stability reports to support clinical batch release. Author GMP/GDP SOPs, develop training, and manage internal and external quality events including deviations, investigations, and CAPAs. Provide Quality input to CMC regulatory submissions and support inspection readiness activities. Maintain GDP compliance for clinical trial material distribution and cold chain oversight. Requires 6 years' experience with a life science MS, proficiency with electronic QMS platforms, and ability to travel up to 15%.
Required Qualifications
- 6 years' experience with a MS (organic chemistry, biology, analytic or related life science)
- progressively more responsible QA and analytical related scientific/technical discipline
- equivalent combination of education and relevant experience in the pharmaceutical industry
- relevant experience in a GMP environment
- Hands-on External Quality oversight for clinical phase
- extensive QMS experience
- Deep understanding of analytical and QC operations
- Deep understanding of CMC
- Deep understanding of regulatory requirements
- Deep understanding of best industry practices
- proven matrix leadership in managing cross-functional teams
- Recognized as a subject matter expert within the organization
- ability to solve advanced GxP problems
- ability to guide others
- Proficiency with electronic QMS platforms (e.g. Veeva Vault, MasterControl or equivalent)
- Fluent English
- Ability to travel up to ~15% to CDMOs
Desired Qualifications
- Familiarity with QP batch certification (EU Annex 16)
- Familiarity with GDP Responsible Person role
- Start-up or lean-team experience
- German, French and/or Spanish
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