Quality Manager (m|f|d) Fixed-term, 24 months at Miltenyi Biotec

Bergisch Gladbach, North Rhine-Westphalia, Germany -

Full Time

Start Date

Immediate

Expiry Date

08 Mar, 26

Salary

0.0

Posted On

08 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management System, Deviation Management, OOS Investigations, CAPA Management, Change Control, Document Management, GxP Regulations, GMP, GCP, GDP, GVP, Cross-Functional Project Management, Root Cause Analysis, Trend Evaluation, Training Coordination, Compliance

Industry

Biotechnology Research

Description

Company Description Miltenyi Biomedicine is a biopharmaceutical company committed to advancing personalized cell and gene therapies. We are pioneering groundbreaking therapies for serious life-threatening diseases, and reshaping their accessibility for clinical professionals and patients worldwide with the aim to improve and extend patients' lives. We are currently focusing on difficult-to-treat hematological cancers using CAR-T and other technologies, while also exploring treatments for other diseases. Our lead candidate, a tandem CAR-T cell product, is currently undergoing pivotal clinical trials on a global scale. Join our highly professional team in bringing new medicines to market and ensuring the safety of our pharmacological developments at all stages. Job Description As Quality Manager, you will play a key role in maintaining and enhancing MBM’s Quality Management System (QMS) to ensure continuous compliance with applicable GxP regulations, corporate standards, and quality objectives. You will oversee daily quality operations, drive continuous improvement initiatives, and provide quality guidance across the organization. As a valuable member of the Quality Management Team: You will oversee deviations, OOSs, and complaint handling in compliance with GxP; next to this, review and approve records ensuring thorough investigations, root cause analysis, and effective CAPA implementation. You will maintain and continuously improve the QMS, including document and change management, by ensuring all QMS documents (policies, SOPs, work instructions) remain compliant and up to date. You will develop and implement GxP training programs; additionally, you monitor onboarding and refresher training compliance and collaborate with managers to ensure staff qualifications. Next to this, you supervise lifecycle management of controlled documents and records by managing QA SharePoint to guarantee accurate and accessible documentation. In addition, you will provide proactive quality guidance and support, work closely with cross-functional teams to resolve issues and foster a culture of compliance and continuous improvement. Qualifications As a Quality Manager, you hold a university degree and/or proven equivalent experience in a relevant area, ideally in biosciences or pharmacy. You are proficient in deviation management, OOS investigations, CAPA management, change control, and document management under GxP regulations. You are naturally detail-oriented and highly organized, you have an understanding of GMP, GCP, GDP, or GVP requirements and their practical application in QM processes. You bring experience in cross-functional project management, working closely with management team, and regulatory authorities to perform root cause analysis, trend evaluation, and implement effective corrective/preventive actions. With your strong communication skills, you coordinate training activities for GxP-regulated departments. Additional Information Further information This role is offered on a fixed-term basis for 24 months What we offer Working with free and self-determined time management, also mobile working An intercultural environment characterized by diversity and flat hierarchies Freedom to contribute creatively and play an active role in shaping the company Individual further training in our Miltenyi University as the core of the Miltenyi DNA 30 days of vacation, discounted Deutschland-Ticket , (e)-bike leasing, capital-forming benefits, company pension plan, disability insurance, canteen, and much more. 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. We look forward to your application If you want to work in an open, creative and supportive team, this is the place for you. We look forward to receiving your application along with your salary expectations and availability.

Responsibilities

As Quality Manager, you will maintain and enhance the Quality Management System to ensure compliance with GxP regulations and corporate standards. You will oversee daily quality operations, drive continuous improvement initiatives, and provide quality guidance across the organization.