Senior Operational Excellence Quality Lead (all genders), full/part-time

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:
Reporting to Head of Central Quality System at R&D Quality Risk Management (QRM), the Senior Operational Excellence Quality Lead is responsible for the delivery, review and lifecycle management of global and local procedures in the scope of GLP, GCP and GVP activities conducted by Merck Healthcare R&D. This role initiates and leads processes and procedures updates with business process owners, in line with change management process, by providing guidance on document structure and content, regulatory requirements and driving lean process optimization. Maintaining a lean and effective Central Quality System enables Merck Healthcare R&D adherence to regulatory requirements and therefore is a key element of regulatory inspections. You will lead projects / initiatives related to the procedures management.

Who You Are:

• University degree (preferably in Life Science related subject) or equivalent professional experience and expertise

• Lean & Six Sigma certification and/ or Business Process Management certification is a plus

• Minimum 5 years Quality Assurance experience or relevant experience in quality management, biopharmaceutical, clinical development, or regulatory compliance.

• Extensive working knowledge of international regulations and broad working knowledge in compliance areas of GCP, GVP, GLP.

• Broad understanding of the drug development process and regulatory environment including specific areas of interest for Merck Healthcare

• Experience of at least 3 years in process design, description, and good writing skills (e.g., as Medical or Technical Writer) is a plus

• Archiving management or similar experience is a plus

• Professional experience in an international environment for more than 3 years

• Professional experience in project management

• Professional experience in several international pharmaceutical organizations is a plus

• Experience with process design tools is a plus

• Fluent in English

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!

Apply now and become a part of our diverse team!