Facilities and Compliance Manager

The Facilities and Compliance Manager is responsible for ensuring that facility equipment, utilities, and support systems are maintained in a state of control and compliance with cGMP, GDP, and applicable regulatory requirements. This role provides oversight of preventive and corrective maintenance activities, environmental and facility data review, trending and analysis, including health and safety programs meeting OSHA and EPA standards. The position works cross-functionally with Quality, Operations, Engineering, and approved service providers to ensure facility-related risks to product quality are identified, assessed, and mitigated. Key Outcomes Expected Facilities OversightOwn and administer the facility preventive maintenance (PM) and corrective maintenance program for GMP and support equipment. Manage calibration program. Ensure equipment, utilities, and critical systems are maintained in a qualified and compliant state. Maintain and operate temperature-controlled environments Oversee cleanroom infrastructure Support facility qualification (IQ/OQ/PQ) and change controls Manage contractors, vendors, and service providers Ensure business continuity for temperature-sensitive operations Leads emergency response plan / business continuity program Own site pest control program in compliance with cGMP and GDP expectations Manage contracted pest control vendor and service performance Maintain trend analysis, inspection logs, and corrective actions Support audit readiness related to contamination control Data Review, Trending and Analysis Perform routine review of facility-related data, including environmental monitoring, temperature/humidity, pressure differentials, and equipment alarms. Trend data to identify adverse trends, recurring issues, or loss of control. Prepare periodic summaries and reports for Quality and Management Review. Ensure data integrity principles (ALCOA+) are applied to all facility and monitor data. Quality & Compliance Ensure facility activities comply with cGMP, GDP, internal SOPs, and customer requirements. Support internal and external audits and inspections, including preparation of documentation and responses. Ensure facility-related SOPs, logbooks, and forms are current, controlled, and effective. Provide training and guidance to facility and operations personnel on GMP expectations and procedures. Continuous Improvement Identify opportunities to improve facility safety, reliability, compliance, and efficiency. Identify cost saving measures and streamline waste streams as it relates to facilities operation. Support risk assessments related to facility systems and infrastructure. Participate in cross-functional projects and continuous improvement initiatives Critical Skills, Knowledge, and Behaviors Demonstrated experience with facility maintenance programs, data review, and compliance oversight. Knowledge of hazardous materials storage and compliance. Experience managing or overseeing pest control programs in GMP environments preferred. Strong understanding of cGMP, GDP, OSHA and regulatory expectations for safety, facilities and equipment. Experience with data trending, root cause analysis, and CAPA management. Familiarity with commissioning, qualification, and change management processes. Strong organizational, documentation, and communication skills. Ability to work effectively across functions and with external service providers. Education, Experience, Degrees, LicensesBachelor's degree in Engineering, Facilities Management, Life Sciences, or a related field (or equivalent experience). Minimum of 3-5 years of experience in a GMP-regulated environment (pharmaceutical, biotech, medical device, or GMP logistics). Physical Demands: Must be able to operate computer and other office equipment. Must be able to lift up to 50lbs, walk, bend, push, reach. Ability to sit or stand for hours at a time. Normal Warehouse and office demands. Noise level generated from other distribution activity can be somewhat loud at times, but no damaging levels or protective equipment required. Temperature in the distribution center can vary greatly between temperature-controlled zones Work Environment: Work is performed in an Office/Warehouse environment. Work performed in office, warehouse, and controlled GMP environments. May require on-call support for critical facility issues. Occasional off-hours or weekend work to support maintenance or inspections. Disclaimer: This job description is not intended to be all-inclusive. This position may be required to perform other related duties assigned to meet the ongoing needs of the organization. Langham reserves the right to modify job responsibilities and expectations as business demands evolve.

Created: 2026-03-04