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

Bergisch Gladbach, North Rhine-Westphalia, Germany -

Full Time

Start Date

Immediate

Expiry Date

08 Oct, 26

Salary

0.0

Posted On

10 Jul, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management System, GxP Compliance, Regulatory Affairs, Computer System Validation, Internal and External Auditing, CAPA Management, Change Control, Quality Risk Management, ISO 13485, ISO 9001, MDR, 21 CFR 820, Leadership, Stakeholder Management, KPI Trending, Quality Governance

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 Director Global Quality Systems & Compliance, to lead the company‑wide development, implementation and continuous improvement of our quality and compliance systems in a hybrid regulatory environment covering both pharmaceutical and non‑pharmaceutical operations. The overarching objective of this position is to ensure a robust, effective, and integrated Quality Management System that meets regulatory, normative, and internal requirements across pharma, medical devices and ISO regulated activities and supports the organization’s long‑term performance and continuous improvement. In this pivotal role, you will develop, maintain, and continuously improve a global Quality Management System (QMS) that meets Global GxP requirements, MDR, ISO standards and other applicable regulatory and compliance requirements across Pharma and Non‑Pharma Operations. By creating clarity, consistency, and scalability between regulatory requirements and business processes, you enable compliance, operational excellence, and long‑term business success. You will provide QA oversight for Computer System Validation (CSV) activities, including the development and maintenance of IT system workflows as well as oversight of digital solutions and AI‑supported capabilities from a quality and compliance perspective. It is also part of your role to develop, implement, and govern global quality processes, such as Document Management, Training Management, Deviation Management, CAPA Management, Change Control, and Quality Risk Management (QRM). You will lead and coordinate global Quality Compliance activities from Internal and External Audit programs to Third‑party Qualification and Oversight, Product Complaint, Issue & Recall Management. Included are also activities like the definition and trending of Quality KPIs and performance metrics, leading Quality Management Reviews (QMRs) and support Annual Product Quality Reviews (APQRs). You act as a strategic quality partner for senior stakeholders, ensuring alignment between regulatory expectations and business objectives, and promote a culture of quality and compliance, ensuring systems are not only documented but effectively embedded and lived across the organization. Qualifications 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 combined with multiple years of relevant professional experience in Quality Systems and/or Quality Assurance in a regulated pharma environment. Additional qualifications in Quality Management (e.g. as lead auditor) are advantageous but not mandatory. You have extensive experience in Quality Assurance (ie. Quality Compliance and Quality Governance) and Quality Systems activities in a Pharma/Biotech and possibly Medical Device company. Your thorough understanding of global GxP regulatory requirements incl. FDA, EMA, ICH, ATMPs, MDR, ISO (13485, 9001) and 21CFR820 sets you apart. You have a proven track record in building and maintaining a global Quality System incl. quality processes and IT workflows. Leading or participating in Health Authority inspections and customer audits is familiar to you. Your excellent track record includes leading Quality compliance activities including auditing, quality KPIs and QMRs. You are experienced in leading teams and in interacting and collaborating with external customers across cultures and regions (in English and in German). You combine the ability to navigate regulatory complexity in a pragmatic and business-oriented manner with analytical, structured thinking and a confident yet collaborative leadership approach. Additional Information 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. Department: Quality Management Representative Location: Bergisch Gladbach Functional Area: Qualitymanagement Company: Miltenyi Biotec B.V. & Co. KG

Responsibilities

Lead the development and continuous improvement of a global Quality Management System across pharmaceutical and non-pharmaceutical operations. Provide QA oversight for computer system validation, digital solutions, and global compliance activities including audits and risk management.