(Senior) Quality Assurance Manager – External Manufacturing (Cell Therapies at Miltenyi Biotec

Bergisch Gladbach, North Rhine-Westphalia, Germany -

Full Time

Start Date

Immediate

Expiry Date

22 Sep, 26

Salary

0.0

Posted On

24 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, External Manufacturing Oversight, GMP Compliance, Cell Therapies, ATMP Regulations, Technical Transfer, Quality Management Systems, Third-party Qualification, Regulatory Inspections, APQR Authoring, KPI Reporting, Stakeholder Management

Industry

Biotechnology Research

Description

Company Description For more than 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 5,000 experts from over 75 countries contribute to our sustainable success. Job Description We are seeking an experienced professional taking overall responsibility for ensuring quality and regulatory compliance across external pharmaceutical manufacturing operations, with a strong focus on cell therapies. You provide Quality Assurance oversight for all external pharmaceutical manufacturing activities performed on behalf of Miltenyi or external clients related to cell therapies, ensuring compliance with applicable quality and regulatory requirements. You support technical transfers of pharmaceutical products, ensuring consistent implementation of processes, product characteristics, and quality standards. You ensure alignment between internal and external manufacturing activities, product characteristics, and quality expectations. You support the investigation, assessment, and resolution of quality-related issues, particularly those impacting product quality, patient safety, and regulatory compliance. Included is also the contribution to the development, implementation, and ongoing maintenance of the Global Quality Management System in accordance with current global regulatory requirements. In addition, you contribute to the collection and reporting of Quality KPIs, performance of Quality Management Reviews (QMRs), and the authoring of Annual Product Quality Reviews (APQRs). You support third-party qualification, auditing, and contracting activities as well as regulatory inspections and customer audits at external manufacturing sites, as required. You provide input to and review regulatory documentation as needed. Qualifications You hold a university degree (bachelor's or higher) in a relevant scientific or technical discipline, such as Pharmaceutical Sciences, Biology, Biotechnology, Chemistry, Biochemistry, Engineering, or a related field. You bring several years of experience in operational Quality Assurance and Quality Systems in a GMP-regulated pharmaceutical or biotechnology setting, ideally with exposure to Pharma CDMOs. You have a thorough understanding of global GMP/GDP regulatory requirements and knowledge of and experience with ATMPs related operations and requirements, ideally including experience with clinical and commercial products. Your proven track record of actively supporting and facilitating technical transfer activities and profound understanding of related regulatory and operational requirements sets you apart. You bring along hands‑on experience in QA oversight of external manufacturing partners, and/or third‑party management. Interacting and collaborating with Pharma clients in an international, cross‑cultural and multi‑regional environment is familiar to you as well as successfully leading regulatory inspections and managing and resolving global issues. You have experience with building and maintaining an adequate Pharma QMS acc. FDA, EMA, ICH, ATMP and local regulatory requirements. You bring a strong drive to establish a new role, combined with a proven ability to develop, implement and sustainably embedded structures and processes that ensure long‑term success. You are proactive, solution-oriented with a passion for shaping the future. You have excellent communication skills with the ability to collaborate effectively with a broad and diverse range of stakeholders, including international partners Ideally, you have some initial experience in a leadership role. Further information: The role requires travel of approximately 20–30% Additional Information 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: We offer a wide range of corporate sports activities and health provision Miltenyi University: A clever mind never stops learning, take advantage of our in-house Training Academy 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. Become part of our team and focus on pushing the borders of medicine. Contact us If you have the skills and qualifications for this position, please use the link to send us your details (application letter, curriculum vitae, references and certificates). Please give us some idea of when you can start and the kind of salary you are looking for. Department: Quality Assurance Location: Bergisch Gladbach Functional Area: Qualitymanagement Company: Miltenyi Biotec B.V. & Co. KG

Responsibilities

The role is responsible for ensuring quality and regulatory compliance across external pharmaceutical manufacturing operations for cell therapies. This includes overseeing technical transfers, managing external partners, and maintaining the Global Quality Management System.