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Thermo Fisher Scientific Sr. Manager, Quality in Carlsbad, California

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.

Location/Division Specific Information

This role is responsible for quality within the Cell Biology business unit in Carlsbad and has broad multi-site responsibility across 15 manufacturing sites. With a strong focus on new products and new technology, Cell Biology is one of our fastest growing businesses with current revenues > $1 Billion.

How will you make an impact?

As the Quality Leader for the Carlsbad site, you'll be a key member of the Leadership Team. You'll be a strategic partner who will help drive improvements across division and sites to support business objectives. You'll be a Quality Champion for Product Development Stages all the way to service, support and post market surveillance. Our Quality strategy is to expand the influence of Quality beyond operations to ensure optimal product quality and customer experience

What will you do?

  • Cell Biology Quality Leader- You'll be responsible for post market surveillance and complaint analysis for the Business Unit (BU), follow up on key customer facing issues and ensure effective closure of key complaint cases. Ensure closure of compliance gaps across the BU quality systems for all sites. You'll be responsible for managing internal and external audits as well and maintaining and managing all ISO 9001 Quality System Elements.

  • Quality System Improvement Driver-You'll drive best practice sharing and implementation of key improvements for all sites manufacturing product for BU. Drives a common Quality Strategy across BU portfolio. Use PPI (continuous improvement tools) to promote and lead BU Quality System improvements and in particular, this leader would be responsible for ensuring the Cell & Gene Therapy (CTS) products meet the appropriate quality standards across all sites.

  • Leverage Global Quality resources-Connects the BU and collaborates with global quality teams and resources.

How will you get here?

  • Bachelor's degree of science or engineering required.

  • 7+ years of related experience within quality management and quality systems preferred.

  • Quality Management for a Life Sciences business.

Knowledge, Skills, Abilities

  • Quality Management System knowledge.

  • Regulated Quality Systems.

  • Strong business acumen.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and saferer.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.