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Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office
Join Thermo Fisher Scientific Inc. as a Sr Manager, Quality in our Manufacturing division, where you will play a meaningful role in driving excellence and innovation. We are seeking an ambitious and proven leader to ensure our quality systems meet the highest standards. This is an outstanding opportunity to work in a multifaceted environment where your contributions will make a significant impact!
Preferred Education & Experience
- A professional qualification and/or scientific degree (or equivalent)
- Extensive experience in a busy QC or QA environment, ideally within medical device or pharmaceutical manufacturing industries
Key Responsibilities
- Manage the Quality System in strict compliance with ISO and cGMP standards and regulations
- Provide mentorship, promoting these standards throughout the company
- Lead, empower, and guide the Quality Assurance and Quality Control teams
- Stay current with regulatory requirements, particularly cGMP and the European/United States Pharmacopeia standards
- Discuss regulatory requirements with management and liaise with customers as needed
- Coordinate critical review of product batch records before final product release
- Manage the validation process in accordance with regulatory guidelines
- Host and manage customer audits, ensuring corrective actions are completed
- Handle the Customer Complaints system efficiently
- Review quality agreements internally to determine their implications and ensure compliance with customer requirements
- Manage the Supplier Quality audit programme and implement quality agreements for suppliers
- Provide technical assistance to the Commercial team and other internal departments
- Operate within departmental capital and expense budgets
- Ensure H&S compliance in line with UK legislation within the remit of the role
- Perform any other tasks as deemed appropriate by the site or Quality leadership
Become a part of our world-class team, where you can make a real difference!
