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

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 :

Additional Information :

This position is limited to 24 months.

What we offer

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 peoples lives.

Remote Work : No

Employment Type : Full-time

Key Skills

Lean Manufacturing,Project Management Methodology,Kanban,Employee Relations,Succession Planning,Continuous Improvement,SyteLine,Conflict Management,Operations Management,Interpretation,Leadership Experience,Plant Management

Experience : years

Vacancy : 1