QA Manager Cell Factory - Inspection readiness (m|f|d)

Company Description

For 35 years, we have been developing innovative medical devices to empower biomedical research and advance medical treatments. This is how we are pushing the boundaries of cell and gene therapy and personalized medicine. 
To realize our vision we combine sophisticated research with advanced engineering solutions in agile software development, data science, internet of things, artificial intelligence and connectivity. Today, more than 4,900 experts from over 50 countries contribute to breakthrough innovations and sustainable success.   

Job Description

As QA Manager Cell Factory you play a critical role in ensuring the highest standards of quality assurance and regulatory compliance within our organisation. This position demands unwavering attention to detail and a commitment to excellence in all aspects of quality management.

• Maintain rigorous inspection readiness from a QA perspective, collaborating extensively with operational departments, project managers, and other QA teams. Implement and oversee robust systems for continuous monitoring of commercial manufacturing processes to ensure strict GxP compliance.
• Ensure absolute adherence to all applicable quality standards and regulations, including GxP, EU Guidelines, and 21 CFR 820.20b.3. Vigilantly maintain RA & GMP compliance and conduct thorough assessments of new regulatory requirements to safeguard organisational integrity.
• Prepare, review, and approve critical quality documents, including batch records, SOPs, test procedures, and risk assessments. Spearhead initiatives for continuous improvement of GMP compliance and quality systems within the Cell Factory, with a focus on maintaining the highest standards of excellence.
• Orchestrate the alignment of QA topics across Cell Factories within Miltenyi. Establish and maintain transparent, professional communication channels and facilitate the exchange of crucial information between QA, operational departments, and external partners.
• Develop and implement comprehensive measures to address gaps and audit deficiencies, with stringent tracking of related actions. Provide expert support for decentralized manufacturing and point-of-care approaches for CGT, ensuring compliance at every stage.
• Serve as the primary point of contact for external support activities, demonstrating authoritative decision-making in QA-related matters. Oversee and support rigorous employee qualification monitoring and participation to maintain the highest standards of competence within the organisation.

Qualifications

• A degree in Pharmacy, Biology, Biochemistry, or Medicine is required, along with several years of experience in the commercial pharmaceutical industry.
• Extensive experience across various QA functions and comprehensive knowledge of international and national cGxP regulations and the regulatory environment are essential.
• Familiarity with aseptic processes and Cell & Gene Therapy (CGT) is crucial. Knowledge of development requirements and GCP regulations is highly advantageous.
• Demonstrated experience in preparing for and hosting inspections by local and international health authorities (e.g., EU, FDA) is imperative.
• Superior critical communication skills, proficiency in managing multiple GMP topics simultaneously, and the ability to proactively identify risks while proposing effective mitigation strategies are paramount.
• Fluency in English and German (both spoken and written) is mandatory, accompanied by exceptional presentation skills, a highly structured working style and analytical mindset.

Additional Information

This position is limited to 24 months.

What we offer

• Flexible and remote work: Enable time management on your terms
• Diversity: International teams and cross-border intercultural communication
• Room for creativity: It’s the most clever solution that we always strive for
• Health & Sport: Corporate sports activities and health provision
• Miltenyi University: A clever mind never stops learning, take advantage of our inhouse Training Academy
• Corporate benefits: Employee events, 30 days of vacation, (e)-bike leasing, company pension plan and many other offers

Contact us 

If you are passionate about the purpose of your code and enjoy working in a supportive team culture, then please do not hesitate to join us in our great vision and make a real difference to people's lives.