Director Global Quality Systems & Compliance (m|f|d)

Miltenyi Biotec; Moitzfeld; Hybrid; EUR 150.000 - 210.000; Vollzeit

Benefits dieser Stelle

Miltenyi University

Diversity is the bedrock of creativity

International teams

Zusammenfassung

Miltenyi Biotec in Germany seeks a Director Global Quality Systems & Compliance to lead the company-wide QMS, ensuring regulatory, normative and internal requirements across pharma, biotech and medical devices.

You will drive continuous improvement, oversee CSV activities, manage Quality KPIs and QMRs, and partner with senior stakeholders in English and German.

Qualifikationen

• Academic or vocational degree with experience in Quality Systems in regulated pharma or biotech.
• Strong knowledge of global GxP, FDA/EMA/ICH and ISO requirements.
• Experience leading audits, inspections and quality governance activities.
• Proven ability to build and maintain a global QMS and collaborate with diverse teams.

Aufgaben

• Develop, maintain, and improve a global QMS meeting GxP requirements across pharma and non-pharma.
• Oversee CSV activities, IT workflows, and digital solutions from a quality perspective.
• Lead quality processes: Document Management, Training, Deviation, CAPA, Change Control, QRM.
• Coordinate internal/external audits, supplier oversight, and QMRs/APQRs; report KPIs.

Kenntnisse

Global quality leadership

Regulatory compliance

Cross-functional collaboration

Bilingual English/German

Ausbildung

Bachelor's or higher in Biotechnology/ Natural Sciences/ Engineering

Quality/Regulatory qualifications (lead auditor preferred)

Jobbeschreibung

Director Global Quality Systems & Compliance (m|f|d)

• Full-time
• Department: Quality Management Representative

Formore than35years, we have been developingcutting-edgescience and technology to empower biomedical research andpersonalized 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 than5,000 experts from over75countries contribute to our sustainable success.

We are seeking an experiencedDirector GlobalQuality Systems & Compliance,to lead the company‑widedevelopment,implementationand continuousimprovementofourquality and compliance systems in a hybrid regulatory environment covering both pharmaceutical andnon‑pharmaceutical operations. The overarchingobjectiveof this position is to ensure a robust, effective, and integrated Quality Management System that meets regulatory, normative, and internal requirementsacross pharma, medical devices andISO regulatedactivitiesandsupports the organization’s long‑term performance and continuous improvement.

• In this pivotal role, you willdevelop,maintain, and continuously improve aglobal Quality Management System (QMS)that meets GlobalGxPrequirements, MDR, ISO standards and other applicable regulatory and compliance requirementsacross Pharma and Non‑Pharma Operations.By creatingclarity, consistency, and scalabilitybetweenregulatoryrequirements and business processes, you enablecompliance, operational excellence, and long‑term business success.
• You will provideQA oversight for Computer System Validation (CSV)activities, including the development and maintenance ofIT system workflowsas well asoversight ofdigital solutionsand AI‑supported capabilitiesfroma quality and compliance perspective.
• It is also part of yourrole todevelop, implement, and governglobal quality processes,such as Document Management, Training Management, Deviation Management, CAPA Management, Change Control,and Quality Risk Management (QRM).
• You will leadand coordinateglobal Quality Compliance activitiesfrom Internal and External Audit programs to Third‑party Qualificationand Oversight, ProductComplaint, Issue & Recall Management.Included are also activities likethedefinition and trending ofQuality KPIs and performance metrics,leadingQuality Management Reviews (QMRs)andsupportAnnual Product Quality Reviews (APQRs).
• You act as astrategic quality partnerfor senior stakeholders, ensuring alignment between regulatory expectations and businessobjectives, and promote aculture of quality and compliance, ensuring systems are not only documented but effectively embedded and lived across the organization.
• You hold an academic degree in a scientific or technical discipline (e.g., Biotechnology, Natural Sciences, Engineering, or related field)and/or have alternatively a completed vocational qualification combinedwith multipleyearsof relevant professional experiencein QualitySystemsand/orQualityAssuranceina regulatedpharmaenvironment.
• Additionalqualifications in Quality Management (e.g.aslead auditor) areadvantageousbut not mandatory.
• You have extensive experience in Quality Assurance(ie.Quality Compliance and Quality Governance)and Quality Systemsactivities in a Pharma/BiotechandpossiblyMedical Device company.
• Your thorough understanding of globalGxPregulatory requirements incl. FDA, EMA, ICH, ATMPs, MDR, ISO (13485, 9001) and 21CFR820sets you apart.
• You have a proventrack recordin buildingandmaintaininga global Quality System incl.quality processes and IT workflows.
• Leading orparticipatingin Health Authority inspections and customer auditsis familiar to you.
• Your excellenttrack recordincludesleading Quality compliance activities includingauditing, quality KPIs and QMRs.
• You are experienced in leading teams and in interacting and collaborating with externalcustomersacross cultures and regions(in English and in German).
• You combinethe ability to navigate regulatory complexity in a pragmatic and business-oriented mannerwith analytical, structured thinking and a confident yet collaborative leadership approach.

What we offer

• Diversity:Internationalteamsandcross-borderinterculturalcommunication
• Roomforcreativity:It’sthemostcleversolutionthatwealwaysstrivefor
• MiltenyiUniversity:Aclevermindneverstopslearning,takeadvantageofourin-houseTrainingAcademy

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.