Senior Quality, Safety, and Compliance Manager | Senior QSC Manager (m/w/d)
Roche Diagnostics GmbH
Job Summary
This Senior Quality, Safety, and Compliance (QSC) Manager role at Roche in Mannheim, Germany, is crucial for ensuring the timely delivery of medicines to patients and maintaining regulatory compliance within Sterile Drug Product Manufacturing (SDPM). The successful candidate will actively champion a Lean-Mindset culture, coach teams on GMP practices, and serve as the primary contact for regulatory authorities to uphold manufacturing and import licenses. Day-to-day responsibilities include strategically developing compliance concepts for new projects, managing critical authority inspections, and advising subsidiaries on import permits. This position offers the opportunity to play a leading role in global GMP assessments and contribute to Roche's vision of providing groundbreaking medicines, making it an attractive role for a seasoned professional passionate about quality and patient impact.
Required Skills
Education
Completed scientific degree (natural sciences), PhD desirable
Experience
- 7-10 years of professional experience in the pharmaceutical industry
- At least 4 years of experience in inspections and dealing with authorities
- Professional experience in various departments (e.g., Production, QA, QC, Development, MSAT)
- Professional experience with international interfaces
- Professional experience in project management
- Professional experience in product transfer and launch
Languages
Additional
- Must be based primarily in Mannheim, Germany.
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