Manager, Facilities Management Compliance

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.

Requirements:

• 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.

Benefits:

• 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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