QA Operations Manager

When you join Thermo Fisher Scientific, you will discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science and with the largest investment in R&D in the industry, you will be empowered to realize your full potential as part of a fast-growing, global organization that values your passion and unique contributions. Our commitment to you and our 80,000 colleagues is to provide the resources and opportunities you need to make a difference in our world while building a fulfilling career with us.

Location/Division Specific Information
At our site in Swindon, we are forging partnerships that are redefining the industry, crafting new business models between pharma companies and their pharma service providers. We offer groundbreaking solutions that are driven by client needs

What will you do?
QA Operations Manager will lead the QA Operations department and all aspects of the people process including hiring, on-boarding, mentoring, coaching, annual objective setting, performance management and employee development.
Key responsibilities:

• The QA Operations Manager reports to the Site Quality Head and manages a team of 4 direct reports (total team of c. 20)
• Assure the proper cGMP compliance status of all the activities conducted at site. Assure appropriate oversight at shop floor level
• Assure the appropriate regulatory and cGMP status of all those documents necessary for the release of the batches produced at site
• Set and maintain a proper quality plan in order to assure the compliance with national and international regulation
• Manage deviation investigation and relevant CAPA identification and execution plan

• Meaningful experience working in a pharmaceutical Quality department on a sterile site.
• Substantial Quality Assurance experience and ‘hands-on’ knowledge of all Quality Systems required for a sterile manufacturing facility.
• Understanding of the principles of sterile manufacturing.
• Understanding of Operational Excellence principles / Lean manufacturing

• This position requires deep understanding and confirmed application of cGMP regulations and international guidelines in a sterile production setting. This knowledge needs to be combined with clear decision-making, pragmatism aligned with quality risk management principles to demonstrate release of product appropriate for commercial use.
• Demonstrated ability to make sound decisions regarding evaluation of GMP compliance, and
• of developing and influencing business strategy is desirable leadership abilities in the management of QA oversight
• Eligible to act as a ‘Qualified Person’ as defined in 2001/83/EC and 2001/82/EC (as amended), is preferable but not essential
• Solid understanding of the principles and guidelines for GMP as set out in the Orange Guide, Eudralex Volume 4, U.S. 21CFR part 210/211 and other relevant regulations
• Confidence in making decisions for the group. Holds self and others accountable in achieving goals
• A proven track record of developing and leading a high performance team
• Strong leadership skills with good collaboration, communication and problem solving skills
• Excellent written and verbal communication skills to internal and external partners
• Wants to learn and have a natural curiosity to understand systems and processes
• Ability to work in a fast paced, matrix environment is important
• Capable of working to deadlines and prioritize multiple tasks
• Flexibility to meet changing needs and priorities of the business

• Science degree in Chemistry, Pharmacy or Microbiology

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.