Manager Facilities Management (FM) Compliance

Role Summary

The Manager, Facilities Management (FM) Compliance is responsible for ensuring Facilities adheres to the highest standards of Facilities Management practices in line with cGMP regulations. Drives development and implementation of comprehensive programs, leading, maintaining, and overseeing processes within Facilities Management to enhance operational capability and ensure compliance. This role collaborates closely with subject matter experts and partners across FM and the CoE to identify compliance needs, mitigate risks, and promote operational reliability. The role is critical to audit readiness and robust traceability of records, and supports calibration/maintenance program relevance and effectiveness. Remote work options may be considered on a case-by-case basis and if approved by the company.

Responsibilities

• 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.

Education

• Bachelor’s or equivalent degree in Science, Electrical Engineering, Mechanical Engineering, Industrial Engineering, or a related technical field.

Experience and Skills

• Required: 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.
• Required: Consistent track record of leading calibration / maintenance programs at a global level, including establishing, maintaining, and auditing processes.
• Required: Experience with Digital & Automated Calibration Systems: Familiarity with calibration management software, CMMS platforms, or automated calibration tools to enhance compliance and efficiency.
• Required: Demonstrated expertise in cGMP, regulatory standards, and risk mitigation related to calibration and equipment reliability.
• Required: Deep understanding of industry-specific standards such as FDA regulations, EMA guidelines, and international calibration standards (e.g., ISO 17025, ANSI/NCSL Z540).
• Required: Experience acting as a Subject Matter Expert (SME) in calibration / maintenance compliance, supporting audits, and implementing continuous improvement initiatives.
• Required: Ability to analyze learning metrics, assess ROI, and continuously improve programs based on data insights.
• Required: Prior leadership experience leading teams or cross-functional projects related to calibration or quality systems.
• Required: Consistent track record to work effectively across multiple regions, cultures, and functions, promoting a unified approach to calibration compliance.
• Required: Experience leading calibration-related projects, process improvement initiatives, or system implementations within a regulated environment.
• Required: Experience developing training programs or mentoring teams to elevate calibration / maintenance practices and compliance awareness organization wide.
• Required: Skilled in conducting risk assessments, root cause analysis, and implementing corrective and preventive actions (CAPA).
• Required: Demonstrated success in leading change initiatives, process optimization, and driving a culture of compliance and operational excellence.
• Required: Strong organizational skills to run multiple initiatives and timelines.
• Required: Outstanding interpersonal skills for stakeholder engagement, presentations, and influence at senior levels.
• Preferred: Advanced certifications such as ISO 17025, GMP Professional, or Calibration Technician certifications are highly desirable.
• Preferred: Professional certifications (e.g., PMP, Lean, Six Sigma, etc.).

Additional Requirements

• English proficiency (oral and written) is required.
• This role may require 30% of domestic or international travel.