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

Job Description

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 regulationsProvide mentorship, promoting these standards throughout the companyLead, empower, and guide the Quality Assurance and Quality Control teamsStay current with regulatory requirements, particularly cGMP and the European/United States Pharmacopeia standardsDiscuss regulatory requirements with management and liaise with customers as neededCoordinate critical review of product batch records before final product releaseManage the validation process in accordance with regulatory guidelinesHost and manage customer audits, ensuring corrective actions are completedHandle the Customer Complaints system efficientlyReview quality agreements internally to determine their implications and ensure compliance with customer requirementsManage the Supplier Quality audit programme and implement quality agreements for suppliersProvide technical assistance to the Commercial team and other internal departmentsOperate within departmental capital and expense budgetsEnsure H&S compliance in line with UK legislation within the remit of the rolePerform 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!