Head of Quality Strategy Post-marketing

Vor 7 Tagen


Darmstadt, Deutschland Merck Group 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 the Head of Quality Strategy Post-Marketing, you will lead the development and execution of a global risk-based strategy to ensure proactive quality oversight and compliance with post-marketing processes. You will monitor the execution and quality of these processes through dedicated KPIs and metrics, identifying signals, trends, risks, and gaps, while providing regular updates to the Head of Research & Development Quality and Risk Management (RDQRM).

You will be responsible for maintaining quality oversight across key areas, including Pharmacovigilance (PV), Medical Affairs, Regulatory Affairs, and Subsidiaries ensuring alignment with international and local health authority requirements and company standards. You will provide strategic direction for assigned due diligence projects and lead continuous quality improvements based on audits, inspections, trends, and root cause analyses.

Your role will include evaluating and modifying the RDQRM Post-Marketing strategy to meet the changing needs of the organization, regulatory environment, and industry best practices. You will collaborate closely with executive management and cross-functional business partners to identify compliance risks and drive issue resolution, ensuring the timely communication of critical quality issues, including potential misconduct or significant deviations.

In addition, you will provide expert guidance on GxP regulations and best practices to cross-functional teams, identify relevant governance bodies to foster a culture of quality, and oversee inspection readiness efforts. By creating a global network, you will ensure that quality oversight and related activities align with Medical, Regulatory, and Pharmacovigilance (PV) strategies across regions.

**Who you are**
- Advanced degree in a relevant scientific discipline (e.g., pharmacy, medicine, or life sciences).
- Minimum of 10 years of comprehensive experience in QA or relevant medical quality management, biomedical science, clinical development, or regulatory compliance.
- Proven ability to function autonomously at a senior level in a matrix model and team environment.
- Experience in a senior management role with accountability and strong interpersonal, communication, negotiation, influencing, and problem-solving skills, including the successful implementation of continuous improvement initiatives.
- Strong knowledge of ICH GCP and GPV development principles and Quality Assurance.
- Demonstrated ability to work in an international environment leading global quality functions.
- In-depth knowledge of applied risk management, including risk assessment, analysis, evaluation, reporting, communication, treatment, and 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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