Manager QA for Commercial Manufacturing ATMP
vor 2 Wochen
StellenbeschreibungAs a Manager QA for Commercial Manufacturing ATMP you will responsible for Commercial Cell and Gene Therapy Products manufactured within Cell Factory in Bergisch Gladbach.Your main responsibilities include:Ensure inspection readiness from a QA perspective, collaborating with operational departments, project managers, and other QA teams. Continuously monitor commercial manufacturing and implement tools for GxP compliance.Guarantee that all manufacturing operations meet applicable quality standards and regulations (GxP, EU Guidelines, 21 CFR 820.20b.3). Maintain RA & GMP compliance and assess new regulatory requirements.Prepare, review, and approve quality documents such as batch records, SOPs, test procedures, and risk assessments. Drive continuous improvement of GMP compliance and quality systems within the Cell Factory.Align QA topics across Cell Factories within Miltenyi. Foster transparent communication and trustworthy information exchange between QA, operational departments, and external partners.Implement measures to eliminate gaps and audit deficiencies, track related actions, and support decentralized manufacturing and point-of-care approaches for CGT.Act as primary contact for external support activities, drive QA-related decision-making, and support employee qualification monitoring and participation.QualifikationenYou hold a degree in Pharmacy, Biology, Biochemistry, or Medicine and have several years of experience in the commercial pharmaceutical industry.You bring solid experience across various QA functions and possess strong knowledge of international and national cGxP regulations and the regulatory environment.You are familiar with aseptic processes and Cell & Gene Therapy (CGT). Knowledge of development requirements and GCP regulations is a plus.You have experience preparing for and hosting inspections by local and international health authorities (e.g., EU, FDA).You excel in critical communication, managing multiple GMP topics simultaneously, and proactively identifying risks while proposing effective mitigation strategies.You are fluent in English and German (spoken and written), with excellent presentation skills, a structured working style, and an analytical mindset.Zusätzliche InformationenDiversity: International teams and cross-border intercultural communicationRoom for creativity: It’s the most clever solution that we always strive forHealth & Sport: Corporate sports activities and health provisionMiltenyi University: A clever mind never stops learning, take advantage of our inhouse Training AcademyCorporate benefits: Employee events, 30 days of vacation, (e)-bike leasing, company pension plan and many other offersDiversity is the bedrock of our creativity. Our mission: To innovate treatments and technologies and tackle the world’s most serious health challenges. And that’s why we connect the dots –across various disciplines, linking different perspectives, skills, and abilities. You and your talent are welcome here in our inclusive and collaborative environment. So come as you are. Regardless of gender, sexual identity, age, ethnicity, religion or disability. 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.
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Manager QA for Commercial Manufacturing ATMP
vor 2 Wochen
Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biotec VollzeitUnternehmensbeschreibung For 35 years, we have been developing cutting-edge science and technology to empower biomedical research and personalized medicine. We combine excellence from more than 60 disciplines in natural sciences, engineering, and informatics to make a significant contribution to biomedical sciences. We encourage a creative working...
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Manager QA for Commercial Manufacturing ATMP
vor 2 Wochen
Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biotec VollzeitUnternehmensbeschreibungFor 35 years, we have been developing cutting-edge science and technology to empower biomedical research and personalized medicine. We combine excellence from more than 60 disciplines in natural sciences, engineering, and informatics to make a significant contribution to biomedical sciences. We encourage a creative working environment...
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Manager QA for Commercial Manufacturing ATMP
vor 2 Wochen
Bergisch Gladbach, Deutschland Miltenyi Biotec VollzeitManager QA for Commercial Manufacturing ATMP (m|f|d)Quality Assurance - Bergisch GladbachUnternehmensbeschreibungFor years, we have been developing cutting-edge science and technology to empower biomedical research and personalized medicine. We combine excellence from more than disciplines in natural sciences, engineering, and informatics to make a...
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QA Compliance Manager
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Bergisch Gladbach, Deutschland Miltenyi Biotec VollzeitCompany DescriptionFor 35 years, we have been developing cutting-edge science and technology to empower biomedical research and personalized medicine. We combine excellence from more than 60 disciplines in natural sciences, engineering, and informatics to make a significant contribution to biomedical sciences. We encourage a creative working environment...
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vor 1 Woche
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Product Manager
Vor 4 Tagen
Bergisch Gladbach, Deutschland Miltenyi Biotec VollzeitCompany DescriptionFor 35 years, we have been developing innovative medical devices that empower biomedical research and advance medical treatments. This is how we push the boundaries of cell and gene therapy and personalized medicine. To realize our vision, we combine cutting-edge research with advanced engineering solutions in agile software development,...
