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Quality Assurance Manager

2 mesi fa

Seregno, Lombardia, Italia emerson A tempo pieno
European Quality and Validation Manager

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 working on European projects.

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 fully understand customer validation requirements, resolve appropriate project execution processes, and ensure that validation costs are reflected in the bid.
  • Allocate EU CSV resources to projects.
  • Assist the project team in establishing accurate project planning activities.
  • Take responsibility for Validation Lead of specific projects.
  • Develop our QMS (PMO) and project execution tools in line with Life Science industry expectations. Encourage the use of tools on projects.
  • Support EU Quality Managers with External Audits from Life Science Customers.
  • Perform Quality and Life Science training for all relevant functions (Engineers, Project Managers, CSV team).
  • Maintain the global CSV support team, and mentor individual CSV engineers in Europe (indirect reports).
Requirements:
  • 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.
  • Confirmed experience and personal credibility in front of customers and colleagues.
  • Exceptional communication and presentation skills.
  • Ability to establish a quality culture within the engineering Life Science team.
  • Willingness to travel, mostly for short periods, for assessments, workshops, and audits at customer sites, as required.
Preferred Qualifications:
  • 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.
Our Offer:

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.