Manager, Facilities Quality & Compliance (GMP)

Manager, Facilities Quality & Compliance (GMP) Middleton, WI Job Details Full-time 1 day ago Qualifications Quality control corrective actions Regulatory inspections Compliance risk assessment Document review (document control) EHS Pharmaceutical regulatory compliance Safety regulations Compliance audits & assessments Corrective and preventive actions (CAPA) GMP Compliance management implementation CMMS High school diploma or GED Change management Maintenance activity documentation Key Performance Indicators Quality assurance audits Electrical systems Team management Laboratory compliance Pharmaceutical plant experience Workplace health and safety regulatory compliance Maintenance management Quality audits Commissioning phase involvement Senior level Cross-functional collaboration Associate's degree Escalation handling Leadership Risk assessment implementation Technical Proficiency Mechanical knowledge Cross-functional communication FDA regulations Full Job Description Work Schedule Other Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Fluctuating Temps hot/cold, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Various outside weather conditions, Warehouse, Working at heights Job Description 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. 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 role's scope.

Key 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. 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 100,000+ 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!

http:

//jobs.thermofisher.com 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. Accessibility/Disability Access Job Seekers with a

Disability:

Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255•. Please include your contact information and specific details about your required accommodation to support you during the job application process. This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.