Apply now »

We are experiencing a technical issue with the Careers Website. At the moment, applications are not possible. We are working on resolving the issue as soon as possible. Thank you for your patience.

Director, Senior Clinical Quality Management Lead (all genders) - full-time/part-time possible

 

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.


This role involves integrating operational feasibility and stakeholder insights into clinical protocols and quality risk management plans. The CQM Lead supports study teams in developing risk-based monitoring plans, investigates quality issues, assesses their impact, and implements corrective and preventive actions. Collaboration with R&D Quality to co-lead inspection preparation activities is also crucial. The ideal candidate will demonstrate strong leadership, influencing, and project manageement skills and a commitment to maintaining high-quality standards throughout the clinical trial process.

 

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!
 
Apply now and become a part of our diverse team!

 

Job Requisition ID:  283181
Location:  Darmstadt
Career Level:  E - Professional (10+ years)
Working time model:  Full-time

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request.  You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

Notice on Fraudulent Job Offers
Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information.


Job Segment: R&D, Inspector, Quality Manager, Clinic, Research, Quality, Healthcare

Apply now »