Job Title: Senior Manager, Quality Assurance
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.
Division and Location
Laboratory Chemicals Division (LCD) is part of the Life Sciences Solutions Group (LSG) and provides smart chemistry solutions for the pharmaceutical, agrochemical, diagnostic, detection, electronic, fuel cell, paints and coatings markets. We have over 1,200 employees that support our academic, commercial, CRO, industry and government customers from research and development through to manufacturing throughout the world.
Laboratory Chemicals Division provides over 100,000 catalog products ranging from solvents, stockroom and laboratory reagents, catalysts, organic building blocks, screening libraries, analytical standards, bioreagents, precious metals, salts and solutions. They are manufactured and distributed across 13 global sites.
This position will lead Quality Assurance, provide strategic direction and ensure full compliance of regulatory requirements for our Fair Lawn and Bridgewater, NJ sites.
How Will You Make An Impact?
You’ll be driving change as a hands-on, insightful leader mentoring the team and implementing strategic and tactical plans to drive sustainable Quality process improvements. Our commitment to quality is at the heart of our brand and is vital to our growth and success. That’s especially important in our business, because at Thermo Fisher Scientific, product quality can mean ensuring a proper cancer diagnosis, identifying dangerous substances, making an allergy discovery, facilitating a transplant procedure and countless other important outcomes.
What Will You Do?
- Development, implementation, and improvement of quality system policies and procedures supporting 21 CFR 820; ISO9001, cGMP and laboratory related compliance Standards/Regulations to meet and exceed customer expectations.
- Manage multi-site Quality Assurance team; , Quality Systems, Customer Complaints, CAPA, Change Control, QA Audit/Document Control teams; Provide regular mentoring, development, guidance and feedback.
- Work with operations to establish good manufacturing practices and improve quality culture.
- Lead and participate in cross functional teams in new product development, technology transfer, process improvement and general operations.
- Facilitate and participate in regular site product and process quality reviews including Management Review.
- Responsible for monthly site metrics (score card) presentation to Executive Management.
- Assist with investigations of process variance, nonconforming materials and complaints.
- Contribute to the development of the annual Quality Plan. Manage deliverables to key milestones.
- Chair the CAPA and Non-Conforming Materials Boards, coordinate/manage CAPA efforts and interact with customers (internal and external) on a timely manner and inform the customer periodically of progress relating to issued CAPA’s, conducts and or coordinates complaint investigations.
- Act as main contact during FDA inspections, Notified Body (Management Representative), customer audits and other third party Quality System evaluations.
- Embrace our values of Integrity, Intensity, Innovation and Involvement by role modeling these behaviors.
How will you get here?
- A Bachelor’s degree in a technical/science discipline; an advanced degree is preferred.
- A minimum of 7 years of Quality experience in an FDA regulated industry such as Pharmaceutical, Biotech, Food, Medical Device or Chemicals.
- A minimum of 5 years of experience managing, leading and developing a Quality team preferably in multiple locations.
- Significant hands-on experience with quality management systems implementation and improvements.
- Proven experience as a “champion for Quality”
Knowledge, Skills, Abilities
- A demonstrated record of overcoming resistance to change, and driving the adoption of new business processes from a position of direct and indirect/informal authority
- Excellent relationship building and persuasion skills with the ability to motivate and influence others.
- Excellent verbal and written skills to successfully communicate to a variety of internal and external audiences, while counseling, negotiating and formally presenting views and/or technical criteria.
- Certification as ISO 9001, 13485, GMP Lead Auditor a plus.
- Excellent organizational and time management skills.
At Thermo Fisher Scientific, each one of our 65,000 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 safer.