Senior GMP Compliance Consultant | Biologe (m/w/d)
gempex GmbH - THE GMP-EXPERT
Job Summary
This senior role is dedicated to leveraging extensive GMP expertise to consult clients within the Life Sciences industry, focusing on the implementation, optimization, and maintenance of robust quality assurance systems globally. Day-to-day responsibilities include leading general GMP compliance and strategy consulting, conducting thorough audits, gap analyses, and due diligence studies, and providing critical support during official authority inspections. The consultant will also advise on complex supply chain strategies (MAH, MAA topics) and deliver professional training, mentoring, and workshops. Success in this position requires a strong scientific or technical university background, ideally complemented by a PhD, coupled with a minimum of 10 years of experience in GMP compliance consulting. Candidates must also bring 2-3 years of relevant practical experience gained directly on the manufacturer side. The position offers high autonomy, flexible work models, and significant opportunities to shape the expansion of business areas within a specialized consulting firm.
Required Skills
Education
University degree in natural sciences or technology, ideally with a doctorate (PhD)
Experience
- Minimum 10 years in GMP compliance consulting
- 2-3 years relevant practical experience on the manufacturer side
- Professional experience in customer acquisition and continuous client maintenance
- Professional experience in active association work, presentations, and technical contributions
Languages
Additional
- Willingness for project-related travel
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