Manager Facilities Management (FM) Compliance

Johnson & Johnson•Gurabo, PR

4d•Hybrid

About The Position

Johnson and Johnson is recruiting for a(n) Manager Facilities Management (FM) Compliance. The role will be located in Gurabo, Puerto Rico. Remote work options may be considered on a case-by-case basis and if approved by the company. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine The Manager, Facilities Management (FM) Compliance, is responsible for ensuring that Facilities adheres to the highest standards of Facilities Management practices, in line with cGMP regulations. Plays a vital role in driving the development and implementation of comprehensive programs, leading, maintaining and overseeing processes within Facilities Management scope to enhance operational capabilities and ensure compliance. This role collaborates closely with SMEs and partners across FM and the CoE to identify compliance needs, mitigate risks associated with Facilities Management, and promote operational reliability. This role is critical to maintaining audit readiness and ensuring robust traceability of records, which are vital for regulatory compliance. The role ensures that calibration/maintenance programs are continuously reviewed for relevance and effectiveness. Acting as a key enabler in encouraging a learning culture, the role supports the broader organizational effort to build skills, embed best practices, and sustain operational excellence across FM. The candidate for this role will have: Strong technical background in facilities management including calibration management, instrumentation, and quality systems, with extensive experience in regulated environments such as pharmaceuticals, biotech, or manufacturing. In depth knowledge of cGMP, industry standards, and risk mitigation strategies related to calibration programs. Proven record of leadership in handling compliance processes with ability to provide global guidance, influence cross-functional teams, and act as a trusted advisor on calibration compliance. Excellent analytical and problem-solving skills, with a track record of identifying compliance gaps, implementing corrective actions, and driving continuous risk reduction. Strong communication and stakeholder engagement skills are critical, enabling them to collaborate effectively across regions, support audits, and promote a culture of compliance and operational excellence. Key relationships include (but not limited to) FM leadership & Regional teams, Quality, Compliance & Regulatory teams, IT, Supplier/Service Providers, Training & Development, Asset Management, Risk Management & Validation, Manufacturing & Operations, Regulatory Authorities & Industry Bodies.

Requirements

Strong technical background in facilities management including calibration management, instrumentation, and quality systems, with extensive experience in regulated environments such as pharmaceuticals, biotech, or manufacturing.
In depth knowledge of cGMP, industry standards, and risk mitigation strategies related to calibration programs.
Proven record of leadership in handling compliance processes with ability to provide global guidance, influence cross-functional teams, and act as a trusted advisor on calibration compliance.
Excellent analytical and problem-solving skills, with a track record of identifying compliance gaps, implementing corrective actions, and driving continuous risk reduction.
Strong communication and stakeholder engagement skills are critical, enabling them to collaborate effectively across regions, support audits, and promote a culture of compliance and operational excellence.
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.
Consistent track record to work effectively across multiple regions, cultures, and functions, promoting a unified approach to calibration compliance.
Experience leading calibration-related projects, process improvement initiatives, or system implementations within a regulated environment.
Experience developing training programs or mentoring teams to elevate calibration / maintenance practices and compliance awareness organization wide.
Skilled in conducting risk assessments, root cause analysis, and implementing corrective and preventive actions (CAPA).
Demonstrated success in leading change initiatives, process optimization, and driving a culture of compliance and operational excellence.
Strong organizational skills to run multiple initiatives and timelines.
Outstanding interpersonal skills for stakeholder engagement, presentations, and influence at senior levels.
English proficiency (oral & written) is required.

Nice To Haves

Advanced certifications such as ISO 17025, GMP Professional, or Calibration Technician certifications are highly desirable.
Professional certifications (e.g., PMP, Lean, Six Sigma, etc.)

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.