Principal Consultant – Quality Assurance, Pharmaceutical (GMP)
gempex GmbH
full-time
Posted on:
Location Type: Office
Location: Mannheim • Germany
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Job Level
About the role
- General GMP compliance and strategic consulting
- Preparation for and support during regulatory inspections
- Conducting audits, gap analyses, and due diligence studies
- Advising on supply chain strategies (MAH/MAA topics — Marketing Authorisation Holder/Marketing Authorisation Applications)
- Providing training, mentoring, and workshops
- Contributing to the development of internal tools and work aids
- Active participation in professional associations, delivering presentations and technical contributions
- Business development and ongoing client relationship management in consulting projects
Requirements
- University degree in a scientific or technical discipline, ideally with a PhD
- At least 10 years of professional experience in GMP compliance consulting
- 2–3 years of relevant hands-on experience on the manufacturer side
- Excellent written and spoken German and English
- Strong consulting skills and solid technical expertise
- Willingness to travel for project-related assignments
Benefits
- Flexible working hours and location model (remote/hybrid options)
- 30 days of vacation
- Permanent employment contract
- Open corporate culture with flat hierarchies and short decision-making paths
- Attractive benefits package, company car and additional perks
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GMP complianceregulatory inspectionsauditsgap analysesdue diligence studiessupply chain strategiesMarketing Authorisation HolderMarketing Authorisation Applicationstrainingmentoring
Soft Skills
consulting skillsclient relationship managementpresentation skillscommunication skillsbusiness development
Certifications
PhD