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

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.

We are seeking an experiencedDirector GlobalQuality Systems & Compliance,to lead the companywidedevelopment,implementationand continuousimprovementofourquality and compliance systems in a hybrid regulatory environment covering both pharmaceutical andnonpharmaceutical 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 longterm 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 NonPharma Operations.By creatingclarity, consistency, and scalabilitybetweenregulatoryrequirements and business processes, you enablecompliance, operational excellence, and longterm business success.
• You will provideQA oversight for Computer System Validation (CSV)activities, including the development and maintenance ofIT system workflowsas well asoversight ofdigital solutionsand AIsupported 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 Thirdparty QualificationandOversight,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/Biotechand possibly Medical 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 building andmaintaininga 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: 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.

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.