Senior EHS Manager: GMP & R&D Compliance

MedPharm Ltd; Durham (NC); Vor Ort; USD 95.000 - 135.000; Vollzeit

Zusammenfassung

MedPharm US is seeking an EHS Manager to lead Environmental Health and Safety programs across its GMP pharmaceutical manufacturing site and its R&D laboratory, ensuring ongoing regulatory compliance and liaison with regulators.

As an SME, you will independently manage hazard analyses, training, audits, incident investigations, emergency preparedness, hazardous waste, fire/life safety, and site safety culture, coordinating with site leadership to meet KPI targets.

Qualifikationen

• Master's or bachelor's degree in EHS, Occupational Health, Engineering, Science or related field, or equivalent experience.
• Minimum 7 years in EHS within pharmaceutical manufacturing or R&D environments.
• Experience implementing EHS regulations and conducting incident investigations.
• Familiarity with DEA license administration and compliance.

Aufgaben

• Develop and maintain EH&S policies in compliance with regulations and company standards.
• Lead EHS programs, training, inspections, and audits across sites.
• Coordinate Emergency Response and Fire/Safety measures; manage hazardous waste.
• Lead Material Risk Assessments for new compounds and interact with regulators.
• Ensure documentation, records, and training are compliant and retrievable.

Kenntnisse

Regulatory compliance

Incident investigations

DEA Controlled Substances

Risk assessments

SOP & change control

cGMP knowledge

Cross-functional collaboration

Ausbildung

Master's or Bachelor's in EHS or related

Tools

Document management systems

Jobbeschreibung

MedPharm US is seeking an EHS Manager to lead Environmental Health and Safety programs across its GMP pharmaceutical manufacturing site and its R&D laboratory, ensuring ongoing regulatory compliance and liaison with regulators.

As an SME, you will independently manage hazard analyses, training, audits, incident investigations, emergency preparedness, hazardous waste, fire/life safety, and site safety culture, coordinating with site leadership to meet KPI targets.