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
GMP complianceregulatory inspectionsauditsgap analysesdue diligence studiessupply chain strategiesMarketing Authorisation HolderMarketing Authorisation Applicationstrainingmentoring
Soft skills
consulting skillsclient relationship managementpresentation skillscommunication skillsbusiness development
Certifications
PhD