Quality Assurance Manager
il y a 3 semaines
As a key member of our Life Science team, you will be responsible for ensuring the high quality of our projects, meeting customer expectations, and providing leadership to our Validation Engineers. Your role will involve supporting projects from pursuit to execution, performing internal quality audits, and reporting to the Director of Quality Europe.
Key Responsibilities:- Provide mentorship on current industry good validation practices, GxP regulations, and upcoming trends in Life Science compliance.
- Participate in the project pursuit phase to understand customer validation requirements and ensure validation costs are reflected in the bid.
- Allocate EU CSV resources to projects and assist the project team in establishing accurate project planning activities.
- Take responsibility for Validation Lead of specific projects and develop our QMS (PMO) and project execution tools in line with Life Science industry expectations.
- Support EU Quality Managers with External Audits from Life Science Customers and perform Quality and Life Science training for all relevant functions.
- Maintain the global CSV support team and mentor individual CSV engineers in Europe.
- Bachelor's degree or equivalent experience in Engineering or a Technical subject.
- Deep professional understanding of Quality and Computer System Validation within the Life Science sector.
- Strong interpersonal and leadership skills, with confirmed experience and personal credibility in front of customers and colleagues.
- Exceptional communication and presentation skills, with the ability to establish a quality culture within the engineering Life Science team.
- Willingness to travel for short periods for assessments, workshops, and audits at customer sites.
- Technical understanding of Automation (S88), MES (S95), and industrial software.
- Trained in ISO 9001 with auditor training and shown experience.
- Managerial experience in the areas of Operations and Quality preferred.
- Proficient in English + one additional European language preferred.
- Proven experience in efficiently leading, motivating, and developing teams is ideal.
- Possessing an MBA is highly valued.
- Preferably a member of ISPE.
We understand the importance of work-life balance and are dedicated to supporting our employees' personal and professional needs. From competitive benefits plans and comprehensive medical care to equitable opportunities for growth and development, we strive to build a workplace that is encouraging and exciting
Depending on location, our flexible work-from-home policy allows you to make the best of your time, by combining quiet home office days with collaborative experiences in the office so that you can personalize your work-life mix.
Moreover, our global volunteer employee resource groups will empower you to connect with peers who share the same interests, promote diversity and inclusion, and positively contribute to communities around us.
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