Quality Strategy Lead (all genders)

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

The Quality Strategy Lead (QSL) for Post-Marketing is responsible for developing and implementing comprehensive quality strategies for the designated Therapeutic Area or Business area. This role involves designing and executing a risk-based auditing and quality assurance oversight strategy that encompasses regulated activities, including observational/non-interventional studies, disease/drug registries, epidemiology studies, patient support programs, health outcomes, and real-world data usage, along with functional QA support.

As standards and circumstances evolve, you will continuously assess and adapt your approach to align with the organization's changing needs and regulatory landscape. The QSL will also play a key role in providing strategic direction for the preparation, execution, and closure of health authority inspections and external audits in collaboration with the Inspection Management Group. Building strong partnerships with stakeholder groups is essential, as is providing GCP and GVP expertise to ensure ongoing inspection readiness within your area of responsibility.

Who You Are

• Bachelor in scientific or quality-related subjects required. Advanced degree desirable. Equivalent relevant experience maybe considered
• Minimum 5-7 years QA experience or relevant experience in pharmaceutical and/ or biotech industry, in particular clinical quality management, PV quality management, biomedical science, clinical development, or regular compliance with a minimum of 5 years in Clinical / Medical QA
• Broad working knowledge of other GxP disciplines like Medical Devices, GMP or Good Data Management
• In depth knowledge of drug development process and international GCP regulations and pharmacovigilance guidelines
• Fluent in written and spoken English
  
  

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety 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 a team that is dedicated to Sparking Discovery and Elevating Humanity!

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance and Science

• Industries

  Pharmaceutical Manufacturing

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