Director, Senior Clinical Quality Management Lead (all genders)

Posté 31 août 2023

Darmstadt, Hessen - Germany

Demander un identifiant 267217


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 responsible for leading the implementation of risk-based quality management processes across the company’s clinical trial portfolio. These responsibilities include, but are not limited to, leadership of the implementation of quality risk management, risk-based quality oversight, quality improvement, and 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 measures. 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 both inspection readiness is maintained at all times​.  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​.


Who you are:


Minimum Qualifications:

  • Master's degree in Medical or Life Science (or equivalent industry experience) required, PhD preferred. 
  • Expert knowledge of Good Clinical Practice. 
  • Minimum of 12 years’ experience in leading processes related to clinical trial design, planning, start up, conduct, oversight, analysis, and reporting.


Preferred Qualifications:

  • 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 activities.   
  • 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.  Uses appropriate interpersonal skills to influence people (without authority).   
  • Record of successful vendor interactions.   
  • Strong knowledge management, project management and change management skills.  
  • Ability to work in intense, fast paced, matrixed, multinational work environment, fostering collaboration within and across functional areas.
  • 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.  
  • Anticipates issues/needs and acts without being asked or required to; achieves goals beyond job requirements; being proactive; taking prompt action to accomplish objectives.  
  • Ability to act as delegate for the Head CQM.
  • Proficient in verbal and written English. 
  • Cultural awareness. 


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!