Manager, Facilities Management Compliance

🌍 Remote, USA 🎯 Full-time 🕐 Posted Recently

Job Description

Act as the calibration SME within the Facilities Management Center of Excellence (CoE) to ensure calibration program effectively implemented across all manufacturing facilities.
Establish, lead and maintain facilities management programs to ensure compliance with cGMP regulations and industry standards.
Identify risks that could affect product quality, safety, or compliance, and develop strategies to mitigate these risks.
Develop and implement procedures for handling deviations and investigations.
Establish a robust system for managing FM records, ensuring audit readiness and traceability.
Define and implement corrective and preventative actions related to facilities management including calibration issues.
Conduct regular audits and compliance reviews to verify adherence to internal standards and regulatory requirements.
Lead deviation management and facilitate investigations, including audits, to identify root causes.
Analyze trends and lessons learned for continuous improvement opportunities.
Share insights and recommendations to optimize facilities management processes and risk mitigation.
Actively support and advise facilities on calibration-related issues to maintain high standards of equipment reliability.
Monitor calibration processes for efficiency and accuracy and implement process improvements as needed.
Educate personnel on facilities requirements, procedures, and the importance of compliance.

Bachelor's or equivalent degree in Science, Electrical Engineering, Mechanical Engineering, Industrial Engineering, or a related technical field.
Minimum of 6-8 years of hands-on experience in calibration management, instrumentation, or quality assurance within regulated industries such as Pharmaceuticals, Biotech, or Medical Devices.
Consistent track record of leading calibration / maintenance programs at a global level, including establishing, maintaining, and auditing processes.
Experience with Digital & Automated Calibration Systems: Familiarity with calibration management software, CMMS platforms, or automated calibration tools to enhance compliance and efficiency.
Demonstrated expertise in cGMP, regulatory standards, and risk mitigation related to calibration and equipment reliability.
Deep understanding of industry-specific standards such as FDA regulations, EMA guidelines, and international calibration standards (e.g., ISO 17025, ANSI/NCSL Z540).
Experience acting as a Subject Matter Expert (SME) in calibration / maintenance compliance, supporting audits, and implementing continuous improvement initiatives.
Ability to analyze learning metrics, assess ROI, and continuously improve programs based on data insights.
Prior leadership experience leading teams or cross-functional projects related to calibration or quality systems.
Demonstrated success in leading change initiatives, process optimization, and driving a culture of compliance and operational excellence.

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year.
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year.
Holiday pay, including Floating Holidays –13 days per calendar year.
Work, Personal and Family Time - up to 40 hours per calendar year.
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child.
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year.
Caregiver Leave – 80 hours in a 52-week rolling period.
10 days Volunteer Leave – 32 hours per calendar year.
Military Spouse Time-Off – 80 hours per calendar year.

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