Facilities Compliance & Process Lead

What this job involves: The Facilities Compliance & Process Lead ensures the development, implementation, maintenance, and continuous improvement of the Account's Quality & Compliance (QC) and Health, Safety & Environmental (HSE) programs. This role focuses on research and development facilities and strives for compliance with regulatory, procedural, and contractual requirements, ensuring audit readiness across the account.The role involves strong partnership with the maintenance team to ensure adherence to QC and HSE programs, achieving key performance metrics as outlined in client and third-party contracts. The Facilities Process Manager will provide leadership with guidance, identify necessary resources and equipment, and ensure compliance with regulatory and client requirements.What your day-to-day will look like:Quality and Compliance:Develop and implement procedures for maintenance processes.Foster relationships within the account and with clients to promote best practices.Lead the design, development, and sustainability of quality and compliance programs.Share best practices and learnings across the team.Communicate quality assurance expectations and regulatory changes to staff and third parties.Manage quality programs including non-conformance investigations, CAPAs, training compliance, and external audits.Analyze trends and ensure adherence to procedures during process execution.Maintain infrastructure and compliance documentation repository.Drive continuous improvement in processes and client satisfaction.Interface with client personnel to ensure requirements are met and documentation is accurate.Supervise and train team members as needed.Implement and maintain the Life Sciences Quality Management System, including ISO 9001:2015 standards.Health, Safety, and Environmental (HSSE):Develop and implement HSSE management systems and compliance programs.Set and review HSSE performance goals with the team.Track and report HSSE metrics, establishing plans to meet performance indicators.Evaluate safety, health, and environmental risks on client sites.Manage HSSE qualification programs for service partners.Ensure compliance in hazardous waste management and dangerous goods shipments.Identify training needs and coordinate HSSE training sessions.Maintain records in accordance with regulatory and client requirements.Update and enforce HSSE policies and procedures.Assist in accident investigations and implement corrective actions.Maintain liaison with client HSSE organizations to address and resolve issues.Foster a strong HSSE culture.Work Schedule:Monday through Friday (7:00 Am - 4 PM)Desired or Preferred Experience and Technical Skills:General Industry OSHA certifications (CHM, CSHM, CIH, CSP, CEP, etc.)GMP/GxP experience highly desiredFamiliarity with Quality & Compliance regulations and standardsExperience with continuous improvement methodologiesKnowledge of ISO 9001:2015 standards and implementationExperience in R&D or pharmaceutical facility operationsProject management expertiseExperience with computerized maintenance management systemsBackground in change management and process optimizationRequired Skills and Experience:Bachelor's degree in Engineering or related field preferred, with at least eight (5) years of experience in HSSE and Quality Assurance, ideally in life sciences facility operations. Strong-related experience may substitute for a degreeProficiency in Quality Assurance techniques, including non-conformance investigations, RCAs, CAPAs, and audit programsBroad knowledge of Environmental, Occupational Health, and Safety regulationsUnderstanding of cGxP requirements related to facilities, utilities, and laboratoriesExperience working with subcontractors and vendors on quality and safety objectivesProficiency in MS Office (Excel, Word, PowerPoint)Strong communication skills, both oral and written, with the ability to engage with diverse audiencesAbility to prepare and analyze technical reportsExcellent customer service experience#FMjobs

Created: 2025-07-01