Manager, Facilities Quality & Compliance (GMP)

Thermo Fisher Scientific•Middleton, WI

4d•Onsite

About The Position

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. You'll be based at our Middleton, Wisconsin campus, featuring state-of-the-art facilities specializing in chemistry, manufacturing, and control (CMC) analytical services crucial for drug development! Here, our talented team is empowered to showcase Thermo Fisher's commitment to delivering high-quality biopharmaceutical therapies. Join us and be part of groundbreaking research and innovation! Our Analytical Services team is at the forefront of scientific excellence! We offer leading scientific expertise, data solutions, and cutting-edge laboratory technology. Our comprehensive lab services include bioanalytical, biomarker, central lab, CGMP, vaccine sciences, and advanced biostatistics, all designed to support customers in achieving their scientific and operational goals. Position Summary This role supports the Facilities function in Middleton, Wisconsin and provides compliance leadership, guidance, and subject matter expertise for facilities, maintenance, construction, and infrastructure activities within a CFR-regulated GMP environment. The position is accountable for ensuring facilities and maintenance activities are executed and documented in a state of control and in compliance with 21 CFR, GMP requirements, and internal quality systems at the site level. The role partners closely with Facilities, Maintenance, Engineering, Quality, and EHS teams to support audit readiness, change management, and lifecycle compliance of facility systems. This position includes site-level people leadership and performance accountability for facilities compliance activities. The ideal candidate has experience working alongside Facilities and Maintenance teams in a regulated GMP environment, with responsibility for compliance execution, documentation quality, and inspection readiness rather than hands-on maintenance work.

Requirements

Associate’s degree, high school diploma, or equivalent vocational training and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 6+ years). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Previous experience in a regulated GMP environment.
Working knowledge of 21 CFR, GMP principles, and inspection expectations.
Experience supporting regulated operations subject to FDA or equivalent inspections.
Ability to identify compliance risk and raise concerns appropriately.
General understanding of building systems (mechanical, electrical, plumbing, fire protection, automation).
Proficiency with standard computer and documentation systems.
Demonstrates a consistent compliance and risk-aware mindset.
Holds self and team members accountable for quality, timeliness, and regulatory expectations.
Applies sound judgment within defined procedures and escalates appropriately.
Collaborates effectively with execution teams while maintaining compliance independence.
Communicates clearly with cross-functional partners and site leadership.
Manages multiple priorities with attention to detail and deadlines.
Remains effective during change, shifting priorities, and inspection activity.

Nice To Haves

Facilities experience in pharmaceutical, biotech, medical device, or technology environments strongly preferred.

Responsibilities

Provide day-to-day people leadership and performance management for assigned staff, including goal setting, coaching, feedback, and accountability for execution.
Ensure facilities-related work and projects are completed on time and meet quality, regulatory, and compliance requirements.
Execute and enforce compliance requirements for facilities, utilities, and maintenance activities impacting GMP-regulated spaces, in alignment with 21 CFR, GMP standards, and internal SOPs.
Serve as the primary site-level compliance contact for facilities-related quality processes, including review of maintenance documentation and records for inspection readiness.
Partner with Facilities and Maintenance leaders to ensure compliant use of CMMS / CAFM systems and accurate documentation practices.
Support internal and external audits and regulatory inspections, including preparation of documentation and coordination of responses.
Drive timely resolution of QA audit findings, deviations, CAPAs, and effectiveness checks related to facilities compliance, escalating issues as needed.
Author and manage Change Controls related to facilities, utilities, and infrastructure, including completion of risk assessments and impact evaluations within defined approval frameworks.
Maintain and improve compliant processes for Service Requests and Change Control submissions at the site level.
Support updates to facilities-related SOPs through established quality channels.
Provide compliance support for facilities-related commissioning, qualification, and validation activities as required, including review of documentation and drawing traceability.
Partner with Procurement and service providers to support maintenance contracts and adherence to defined scope and KPIs.
Ensure work is performed in compliance with OSHA, EHS, and site policies, maintaining required training and readiness.
Escalate compliance, resourcing, or execution risks that cannot be resolved within the role’s scope.