Environmental Health & Safety Manager

Job Purpose

The Manager of EHS is responsible for leading the Environmental Health and Safety programs and activities in support of MedPharm US sites, including the GMP pharmaceutical manufacturing site and the Research and Development laboratory site. This manager position represents MedPharm on all regulatory matters related to EH&S across both locations.

About the Role

This role spans both a GMP pharmaceutical manufacturing environment and a pharmaceutical R&D laboratory environment and is expected to fulfill all EHS operational responsibilities independently and without direct supervision at each site.

Responsibilities

• Develop/maintain appropriate EH&S policies and procedures in compliance with State, Federal and Local regulatory requirements and company standards.

• Implement EHS programs and procedures that are in line with company requirements and assess the impact to areas affected.

• Able to perform tasks within multiple disciplines of the EHS department as needed and escalate compliance concerns to management team as needed based on risk exposure.

• Analysis of data for regulatory compliance including trending and presentation in management reviews.

• Coincide with employee training in EH&S programs.

• Coincide/Conduct safety inspections/audits.

• Correlate data from inspections with current injury trends as needed.

• Develop and manage an effective Emergency Response Program including leading an Emergency Response Team.

• Coincide with Occupational Health and Ergonomics Programs.

• Coincide with Regulators, acting as primary contact at the sites and follow appropriate escalation procedures.

• Lead the Material Risk Assessment program for all new compounds brought into any of the US sites prior to entering the facilities and trains individuals impacted on safety aspects for handling of the compounds.

• Provide record keeping as necessary to maintain compliance with all local, state, and Federal standards.

• Responsible for defining, reporting and achieving all EHS targets and KPI.

• Initiate and cultivate open, professional relationships with stakeholders by establishing rapport and developing an understanding of others' needs and common goals.

• Oversee the implementation of accident/incident investigation and corrective actions.

• Ensure all (EH&S) training documentation is maintained, and it is readily retrievable for client audits and regulatory agency inspections.

• Guide the incident response team and Site Safety Committee.

• Lead the site’s Hazardous Waste program and activities, and the introduction of new chemicals to the facility.

• Program and sustained safety culture. Strive to be recognized as an industry leader.

• Lead regular site audits and risk assessment activities to ensure company and regulatory compliance in all areas; Track and manage on-time implementation of any corrective action identified during an audit or a risk assessment (FMEA) exercise.

• Engage other department leaders to develop and maintain safety training programs in all applicable areas. Assure training is appropriately documented, regularly reviewed to assure effectiveness, compliance and timeliness.

R&D Site Laboratory and Facility EHS Operations (RTP Site)

• Independently manage the disposal of experimental compounds and study samples, including documentation of chain-of-custody and client-specific destruction requirements consistent with MedPharm’s records retention standards.

• Conduct routine daily and weekly waste management tasks including biohazard waste pickups, chemical waste container management and pickups, broken glassware disposal, and collection of oil waste.

• Perform routine safety and equipment inspections internally and coordinate scheduled preventive maintenance and testing with qualified external vendors, maintaining documentation to support R&D and regulatory compliance.

• Conduct routine eyewash and spill station checks and coordinate annual preventive maintenance on emergency eyewash and safety shower systems requirements.

• Manage the site pest control program, including coordination with licensed vendors and documentation of service records.

• Administer the Bloodborne Pathogen program including exposure control plan maintenance, training coordination, and post-exposure follow-up procedures for the research biology environment.

• Plan, coordinate, and deliver EHS annual training programs for site personnel, ensuring all required curricula including bloodborne pathogens and fire safety are completed, documented, and retrievable for client audits and regulatory inspections.

• Maintain and renew the site’s Controlled Substance License in compliance with DEA and applicable state requirements, including all associated recordkeeping, inventory reconciliation, and reporting obligations.

• Cook up the annual fire safety inspection process including scheduling, preparation of documentation, and closure of any findings, as well as ongoing fire extinguisher and suppression system compliance.

• Prepare and submit all required OSHA year-end documentation including OSHA 300, 300A, and 301 logs and support any related regulatory agency inquiries or inspections.

• Author, review, and maintain EHS-related SOPs and supporting documents within the site quality management system, ensuring alignment with R&D requirements and participation in periodic review cycles and change control processes.

• Support client audits and regulatory inspections by ensuring EHS documentation, training records, waste manifests, and inspection logs are current, organized, and readily retrievable in accordance with R&D expectations.

Qualifications and Skills

• Master's or bachelor's degree in EHS, Occupational Health, Engineering, Science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence.

• Minimum of 7 years in EHS related experience within pharmaceutical manufacturing or R&D environments, required.

• Demonstrated working experience in implementing EHS regulations, conducting incident investigations, interacting with regulatory agencies and external organizations.

• Experience in Risk Assessments & Job Hazard Analysis for pharmaceuticals.

• Familiarity with SOP authorship, change control systems, and document management practices as they apply to EHS program administration in a pharmaceutical CRO or R&D setting.

• Demonstrated success in independent judgment, technical proficiency, scientific creativity, collaboration with others in a cGMP environment.

• Effective knowledge of applicable federal, state and local regulations.

• Familiarity with industry standards, such as NFPA, ANSI, ACGIH, ISO, NIOSH, ASME.

• Familiarity with RCRA, CAA, CWA, NRC, EPA, DEP and Residual Waste Regulations.

• Certification in Safety (CSP), Industrial Hygiene (CIH) and/or Hazardous Materials Manager (CHMM) a plus.