Unternehmensbeschreibung
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 environment driven by pioneering spirit – to seek new horizons – boldly envisioning the future and turning it into reality. Today, more than 4,900 experts from over 50 countries contribute to our sustainable success.
Stellenbeschreibung
As 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.
Qualifikationen
* You 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 Informationen
* 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
Diversity 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.