(Senior) Quality Assurance Manager – External Manufacturing (Cell Therapies) (m|w|d)

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 activitiesperformed on behalf of Miltenyi or external clientsrelated to cell therapiesensuring compliance with applicable quality and regulatory requirements. 
• Yousupporttechnical transfersofpharmaceutical 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 resolutionof quality-related issues particularly thoseimpactingproduct quality patient safety and regulatory compliance. 
• Included isalso the contribution to the development implementation and ongoing maintenance of the Global Quality Management Systemin accordance withcurrent global regulatoryrequirements. 
• 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 asregulatory inspections and customer audits at external manufacturing sites asrequired. 
• You provide input to and reviewregulatory documentation as needed. 

Qualifications :

• You hold a university degree (bachelors 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 proventrack recordofactivelysupportingandfacilitatingtechnical transfer activities andprofoundunderstandingofrelatedregulatory and operational requirementssets you apart. 
• Youbring alonghandson experience in QA oversight of external manufacturing partners and/or thirdparty and collaborating with Pharma clientsin an international crosscultural and multiregional environmentis familiar to youas well assuccessfully leading regulatory inspections and managing and resolving global issues. 
• You have experience withbuilding andmaintainingan adequate Pharma QMS acc. FDA EMA ICH ATMP and local regulatory requirements. 
• You bring a strong drive toestablisha new role combined with a proven ability to developimplementand sustainably embedded structures and processes that ensure longterm success. You areproactive solution-orientedwitha 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 2030% 

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: Its 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 worlds most serious health challenges. And thats 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. 

Remote Work :

No

Employment Type :

Full-time