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Implement and lead environmental, health, safety, and sustainability (EHS&S) program at biologic contract development and manufacturing organization. Responsibilities include incident response, environmental permit management, and risk management. Coordinate with operations to mitigate risks and ensure compliance with EHS&S programs. Conduct audits, inspections, and investigations. Develop and revise EHS&S procedures to promote safety and compliance. Minimum requirements include Bachelor's degree in occupational health and safety field and 3-8 years of industry experience or Bachelor's degree in technical discipline and 5-10 years of experience as a safety professional. Preferred experience in cGMP manufacturing environment.

Provide QA oversight of the Deviations, CAPA, and Complaints organization. Develop and maintain the Quality Assurance staff. Track, trend, compile, and report quality metrics. Support Client Audits and Regulatory Inspections. Partner with Program Management and other departments. Communicate with clients regarding quality-related events.

Senior Quality Assurance Specialist responsible for collaborating with various departments to ensure completion of Root Cause Analysis, CAPAs, and Effectiveness Checks for Deviations according to cGMP requirements. Write Deviation investigations, provide metrics to management, mentor QA staff, and participate in cross-functional teams to improve the Deviation/CAPA system. Review and approve Deviations and CAPAs in support of GMP manufacturing operations.