Massachusetts Green Jobs

Provide quality oversight, technical document review, and approval for the facility, equipment, utility commissioning and qualification, process validation, computer systems, and analytical validation documentation from technical, Health Authority regulations, and BMS policies by drawing on experience with Current Good Manufacturing Practices (cGMP) and regulatory requirements for validation of equipment, computerized systems, and drug manufacturing processes, DeltaV distribution control system (DCS) including configuration, programming, and troubleshooting, contamination control strategies, Medicinal Products Process Validation methodology, life cycle documents, manufacturing methodologies/principles, and cell therapy process, business systems, including SAP, LIMS (Laboratory Information Management System), Maximo, manufacturing executions systems (Syncade), distributive control systems (DeltaV), and PI Historian. Provide quality oversight on Technology Transfer initiatives for Cell Therapy products; verify compliance with applicable Health Authority, BMS Policies, Guidelines, and Directives and ensure consistency with other site procedures and specifications; review and approve process risk assessment FMEAs (Failure Mode Affect Analysis) documents and ensure all mitigation strategies are developed and implemented for risks to product quality throughout the product and process lifecycle; provide guidance, review, and approve the Cell Therapy APS (Aseptic Process Stimulation) risk assessments, study protocols, deviations, summary reports, and procedures/policies; support cross-functional departments MS&T (Manufacturing Science & Technology) planning of validation plan, testing methodology, and test activities; provide Quality oversight to the Devens Cell Therapy Aseptic Process Stimulation (APS) program, including the study strategy, quality risk assessment, investigations, and process improvements; review and approve requirement specifications in validating new or modified processes, systems that supports manufacturing in the plant i.e., User Requirements Specification, Functional Specification, System configuration specification, Design specification, using extensive working knowledge of quality concepts and internal procedures; respond to inquiries from audits and inspections from FDA and world health authorities; support the administration and maintenance of the site change control system, assuring consistency with establishing standards for local and global change control systems, and leads the local change review board; provide Quality impact assessment for Cell Therapy commercial change controls; review and approve the Subject Matter Experts /regulatory impact assessments for completeness and ensure the required actions are initiated to implement the proposed changes; review and approve the change control to ensure health authority and change action are adequately implemented and closed; provide guidance as Subject Matter Expert in the Change Control process; support site deviation investigations and complete implementation of CAPA (Corrective Action and Preventive Action) Actions; ensure that all regulatory and cGMPs compliance items related to validation are satisfied and ensure Validation Master Plan (VMP) adherence; demonstrate appropriate examples for compliance behaviors and attitudes, thereby shaping the culture; meet and exceed all safety expectations and adhere to all BMS behaviors; provide guidance and mentorship; identify, advocate for, and drive opportunities for continuous improvement. May work remotely 5 days every 2 weeks within normal commuting distance of Devens, MA. Requires a bachelor\'s degree in pharmaceutical science, healthcare technology/engineering, or related field +6 years of post-baccalaureate experience showing demonstrable ability in skill set described above. The required skills do not need to be maintained over the full term of req ired experience.