Director, Senior Clinical Quality Management Lead
vor 1 Woche
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 Clinical Quality Management (CQM) Lead is essential in implementing risk-based quality management for clinical trials. Key responsibilities include leading the identification of critical to quality factors, leading quality risk identification, prioritization and mitigation, and overseeing predefined acceptable ranges (e.g., Quality Tolerance Limits - QTLs). The CQM Lead ensures continuous quality improvement and maintains inspection readiness at all times, providing guidance on Good Clinical Practice (GCP) quality principles.
**Who you are**:
- Master's degree in Medical or Life Science (or equivalent industry experience) required, PhD preferred.
- Minimum of 12 years experience in leading processes related to clinical trial design, planning, start up, conduct, oversight, analysis, and reporting.
- Strong understanding of Quality by Design principles, clinical quality risk management processes, risk-based monitoring, and trial oversight.
- Acts as GCP/RBQM SME.
- Strong analytical skills to identify trends and drive quality improvements.
- Ability to make risk-based decisions. Uses appropriate interpersonal skills to influence people (without authority).
- Ability to lead GCP inspection readiness and preparation activities and support global health authority inspections.
- Strong knowledge management, project management and change management skills.
- Proficient in verbal and written 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
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