QA Validation Manager
QA Validation Manager
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Job Description
Were looking for a QA Validation Manager to lead and develop the QA Validation team at a sterile pharmaceutical manufacturing site. This role requires a strong combination of technical validation expertise and effective people leadership. As QA Validation Manager youll play a central role in ensuring compliance across all validation activities while driving collaboration across departments to maintain a robust and inspection-ready quality culture. Keep reading to know more!
The Role
As QA Validation Manager you lead the QA Validation team at our sterile manufacturing site in Brussels. This role combines deep technical expertise in QA validation (equipment processes cleaning CSV) with strong people leadership. Youll be a key voice in project execution resource planning cross-functional collaboration and site readiness for audits and regulatory inspections. Main missions:
- Lead and develop the QA Validation team managing workload priorities and ensuring alignment across CSV equipment and process validation activities.
- Provide expert QA oversight on key validation deliverables including HVAC smoke tests MFT cleaning validation equipment calibration and data integrity compliance.
- Act as QA representative in site projects collaborating closely with Maintenance Engineering MS&T and external partners.
- Ensure regulatory compliance across all validation and qualification processes particularly in relation to computerized systems and data integrity.
- Foster strong cross-functional collaboration promote continuous improvement and reinforce QAs role as a proactive partner across the site.
Qualifications
- Minimum 7 years of QA Validation experience in the pharmaceutical or biotech industry including people management experience.
- Strong expertise in sterile manufacturing and related validation activities (e.g. smoke tests aseptic processes cleaning HVAC).
- Proven experience in Computerized System Validation (CSV) and Data Integrity with solid understanding of regulatory expectations (FDA EU GMP).
- Fluent in English & French.
- Excellent communicator and cross-functional leader with the ability to challenge constructively align stakeholders and lead effectively in a matrix organization.
About the site
At the end of 2024 Novo Nordisk acquired the Catalent Belgium SA manufacturing site.
The site is now part of Novo Nordisk and has begun its transition to become a fully integrated Novo Nordisk manufacturing facility. To support this integration the Brownfield Site Integration (BSI Brussels) team was established with responsibility for managing the local integration and maximizing site capacity in close collaboration with the local team.
About Novo Nordisk
At Novo Nordisk we believe that striving to be the best company in the world is no longer enough we must strive to be the best company for the world. We know this is only possible through the talents of people with diverse ideas backgrounds and cultures. Thats why we are committed to fostering an inclusive culture one that celebrates the diversity of our employees the patients we serve and the communities we operate in. We are dedicated to an inclusive recruitment process and equal opportunity for all applicants.
Application deadline
Please apply before 03/08/25
Required Experience:
Manager
Employment Type
Full Time
