Senior Clinical Quality Management 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:

In your role as Clinical Quality Management (CQM) Lead, you will focus on owning, driving, and continuously improving a robust yet flexible/adaptable inspection readiness process for our clinical trial portfolio.  As owner, you will identify and assess opportunities to simplify and streamline the inspection readiness process seeking to ensure that study teams are effectively and efficiently maintaining inspection readiness at all times.  You will apply a deep working knowledge of health authority inspectorate practices and priorities to consistently guide teams and Business Process Owners to address areas of risk.  You will partner with R&D Quality and Risk Management (RDQRM) leaders to ensure alignment and seamless integration of the inspection readiness,  inspection preparation, and inspection management processes.  You will work directly with clinical program/study teams that are preparing for upcoming inspections to ensure that plans are holistic, impactful, and efficient and that team members are appropriately prepared.  Additionally, you will provide oversight to ensure that inspection preparation risks/issues are effectively managed, driving escalation as needed to minimize risk for the organization.  Finally, you will partner with RDQRM Inspection Management to support program/study teams as needed during and after inspections in order to maximize the likelihood of positive outcomes. 

Who you are:

• Master's degree in Medical or Life Science (or equivalent industry experience) required, PhD preferred. 
• Expert knowledge of Good Clinical Practice and health authority inspection requirements, procedures, and risks. 
• Minimum of 12 years experience in leading processes related to clinical trial design, planning, start up, conduct, oversight, analysis, and reporting.  
• Ability to lead GCP inspection readiness and preparation activities and support global health authority inspections. 
• Ability to identify and overcome process-related risks/issues and inefficiencies.    
• Ability to interpret and apply external intelligence regarding inspection trends. 
• Strong knowledge management, project management and change management skills.  
• Ability to work independently on assigned tasks or projects of increasing complexity and/or sensitivity.   
• Capability to perform self-training, and if assigned able to lead, coach and train others. 
• 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!
 
Apply now and become a part of our diverse team!