Manager, Facilities Quality & Compliance (GMP)

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll 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.

Youll 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 Fishers 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.

Specific 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 roles scope.

Key Requirements:

• Associates 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.

Knowledge Skills Abilities

• 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.

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

General Behaviors

• 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.

Work Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate receive and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

• Able to work upright and stationary and/or standing for typical working hours.

• Able to move effectively throughout facility including lifting and moving objects up to 35-50 pounds.

• Able to work in non-traditional work environments.

• Able to use and learn standard office equipment and technology with proficiency.

• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

• May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.

Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values - Integrity Intensity Innovation and Involvement - working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory with PPD part of Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Apply today!

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.

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