Head of R&d Quality

vor 7 Monaten

Darmstadt, Deutschland Merck KGaA Darmstadt Germany Vollzeit

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

**Your role**: As Head of
**Research & Development Quality (RDQ)** you are accountable to build and lead a Global R&D Quality organization that provides experienced Quality support for R&D programs and projects, including all core quality processes. It is a critical management position within the quality organization that is responsible for the development and strategic oversight of the global R&D quality assurance, quality compliance, and quality systems activities. The position reports into the Head of Regulatory, Quality, and Safety.

You will direct RDQ activities globally to ensure compliance with regulations and our standards. You are responsible to develop the worldwide strategy, policy, and direction for RDQ and continually evaluate the strategic approach to meet the changing needs of the organization, regulatory environment, and industry best practices. Identifying and driving continuous quality process improvements as a consequence of audits, inspections, deviations, trends/metrics, and root cause analysis will also fall into your responsibility. On a regular basis you will collaborate with senior/executive management as well as with other cross-functional business partners, while also ensuring timely and rapid communication on Quality Issues to them. Ensuring oversight on preparation, execution, and close-out of Health Authority/Regulatory Authority Inspections as well as the R&D audit master plan will also be part of your responsibility. Additionally, you will also be responsible for the set-up and implementation of the R&D Risk Management process. Furthermore, you will also represent Healthcare R&D Quality in external seminars, congresses, and quality associations. Budget as well as cost center responsibility will complete this management position.

**Who you are**
- University degree required; advanced degree desirable; equivalent relevant experience may be considered.
- Minimum 10 years Quality Assurance (QA) experience or relevant experience in medical quality management, biomedical science, clinical development, regulatory compliance, risk management or audit management.
- Must have operated in a senior management role with proven accountability and demonstrated excellent interpersonal communication, negotiation, influence, and problem-solving capabilities, including successful implementation of continuous improvement initiatives.
- Prior experience with Regulatory Authority and site inspections.
- Demonstrated strong knowledge of ICH, GCP, PV, GLP development and principles of Quality Assurance.
- Demonstrated ability to work in an international environment leading global (quality) functions.
- Proven leadership and management skills, inspirational as well as motivational leadership style with strong credibility and conflict resolution.
- Demonstrated experience with budgeting and planning.
- In-depth knowledge of applied risk management, including risk assessment, risk analysis, risk evaluation, risk reporting and communication, risk treatment and the review of continuous risk management.

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

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