Director Senior Clinical Quality Management Lead
vor 2 Wochen
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 Senior Clinical Quality Management (CQM) Lead is responsible for leading the implementation of risk-based quality management for the clinical trials that you are assigned to support. As the Director, these responsibilities include, but are not limited to, leading the identification of critical to quality factors, leading quality risk identification and management, leading definition of QTLs and oversight, leading quality issue management and quality improvement, and leading inspection readiness and preparation. As a core member of the clinical study team, the CQM Lead provides guidance on quality principles and performs consistent oversight to ensure adherence to key quality and compliance standards. The CQM Lead is the key quality management interface with trial teams, including with relevant service providers and other internal quality functions.
**Quality by Design (QbD)/Quality Risk Management'‹**
- You lead study teams to identify factors (processes and data) that are critical to quality and to proactively identify, prioritize, and manage important risks to quality'‹.
- Furthermore, you ensure that operational feasibility and patient/site engagement insights are integrated into QbD/quality risk management plans and the associated clinical study protocol.
- You will also lead teams to identify study level quality tolerance limits (QTLs), setting proper thresholds, and consistently overseeing and managing performance'‹ also is part of your role.
**Risk-Based Monitoring**
- Support study teams to ensure that monitoring plans are designed to appropriately focus on critical to quality factors and the associated risks.
- Partner to ensure that selected KRIs focus on at-risk areas and complement QTLs.
**Inspection Readiness and Preparation **'‹
- In addition, you lead study teams to ensure that inspection readiness is maintained at all times'‹ and that fit-for-purpose storyboards are proactively prepared to address key issues, events, and decisions. You also partner with R&D Quality to co-lead inspection preparation activities'‹.
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**Who you are**:
- Master's degree in Medical or Life Science (or equivalent industry experience) required, PhD preferred.
- Expert knowledge of Good Clinical Practice.
- 10+ 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 - as required by ICH E6 R2.
- Ability to lead GCP inspection readiness and preparation activities and support global health authority inspections.
- Acts as GCP/risk-based quality management Subject Matter Expert for clinical study teams.
- Strong data insights and analytical skills to identify trends and drive quality / process improvements.
- Ability to make risk-based decisions based on a robust benefit/risk assessment.
- Strong knowledge management, project management and change management skills. Ability to work proactively and independently on assigned tasks or projects of increasing'¯complexity and/or sensitivity.
You can work your magic from either Europe or USA
**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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