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GMQA-0, Senior Expert, Digital Quality - All Genders

 

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:

We are excited to announce a fantastic opportunity for the position of QA CQV Expert! This role is a key part of our dynamic environment, leading the way in innovation and digitalization within the industry. You will be responsible for maintaining and enhancing the quality management system related to Computerized Systems Validation (CSV) and Data Integrity, ensuring that our site complies with Health Authorities' requirements and Merck Quality Standards for computerized systems implementation.

 

In this role, you will work closely with the Digital and Quality Assurance project teams to ensure that all deliverables meet quality specifications. You will be involved in the review and approval of GxP documents, including User Requirement Specifications (URS), traceability matrices, risk assessments, drawings, procedures, and qualification and validation documents. This is a unique opportunity to promote continuous improvement and drive innovative solutions in a supportive and collaborative environment.

 

We are looking for a passionate leader who can inspire a culture of quality excellence throughout our site.

 

YOUR PROFILE:

  • Graduate degree with substantial to extensive professional experience in relevant fields (mature professional).
  • Senior knowledge and experience in your discipline and beyond, with at least 8-10 years of work experience in quality assurance, quality management, IT compliance, or related areas.
  • Proficiency and comprehensive knowledge of computer system validation (CSV) and Data Integrity requirements as defined by applicable health authorities and industry groups.
  • In-depth understanding of quality management and CSV aspects (cGxPs, 21 CFR Part 11, Annex 11, GAMP) related to computer system applications.
  • Thorough knowledge of regulatory requirements (FDA, EMEA, ICH).
  • Strong attention to detail and excellent organizational skills.
  • Autonomous, organized, and quality-driven with effective communication skills.
  • Results-oriented with a strong focus on customer and quality.
  • Fluency in English is mandatory; knowledge of French is a plus.

 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety 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 a team that is dedicated to Sparking Discovery and Elevating Humanity!
Job Requisition ID:  289252
Location:  Corsier-sur-Vevey
Career Level:  D - Professional (4-9 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.

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Job Segment: QA, Quality Assurance, Quality Manager, Neurology, Oncology, Quality, Technology, Healthcare

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