International GMP Compliance Advisor & Lead Auditor | Chemiker (m/w/d)
B. Braun Melsungen AG
Job Summary
This role involves ensuring global regulatory compliance and quality governance within the Pharmaceutical Quality System for B. Braun's Hospital Care division. The International GMP Compliance Advisor and Lead Auditor will be responsible for planning and executing risk-based international Good Manufacturing Practice (GMP) audits at worldwide B. Braun pharmaceutical sites and external partners (CMOs). Key responsibilities include creating detailed audit reports, evaluating corrective actions, and communicating compliance risks to senior management to inform strategic quality decisions. The successful candidate will leverage deep expertise in international GMP regulations (e.g., EU-GMP, FDA cGMP) and pharmaceutical quality systems (PQS) to identify systemic weaknesses and translate regulatory requirements into practical processes. This position requires significant professional experience in the pharmaceutical industry, ideally in Quality Assurance or Production, and the ability to support sites in preparing for regulatory inspections and certifications.
Required Skills
Education
Bachelor's degree in Natural Sciences or Technology (e.g., Chemistry, Engineering Sciences, or related fields to the pharmaceutical industry), or equivalent qualifications (e.g., Pharmaceutical State Examination). Qualification as a Lead Auditor according to ISO 19011 or a comparable standard is ideal.
Experience
- Several years of professional experience in the pharmaceutical industry (ideally in Quality Assurance, Production, or Regulatory Affairs)
- Experience conducting internal and external audits (suppliers, CMOs, internal sites)
- Experience with international regulatory inspections (e.g., FDA)
- Deep technical knowledge of international GMP regulations (e.g., EU-GMP, FDA cGMP, ICH Q7-Q10, WHO)
Languages
Additional
- Willingness to travel internationally for audits. Hybrid work model.
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