**Location:** Rahway, New Jersey
**Reports to:** FLEx Sterile Compliance Lead, Pharmaceutical Operations & Clinical Supply* Lead the development, maintenance, and assignment of training curricula, ensuring content remains current, relevant, and aligned with compliance requirements.* Monitor, track, and report on training completion, effectiveness, and adoption of training technologies, supporting continuous improvement.* Monitor the facility's environmental monitoring (EM) program, including data review, investigations, and execution of risk assessments to maintain compliance.* Support inspection readiness and participate in internal and external audits, including GMP compliance audits and Safety/GMP walkthroughs.* Review and assess evolving Quality Management System (QMS) documentation and procedures, assessing facility alignment with regulatory and internal requirements.* Manage SOP governance, including periodic reviews and updates driven by quality or operational changes.* Provide oversight for departmental investigations and change controls, ensuring timely closure, robust root‑cause analysis, effective action plans and CAPAs, and trend monitoring.* Oversight and further establishment of the facility Aseptic Observer Program, performing observations, data mining, CAPA development, and cross‑functional communication of results.* Lead operational responsibilities for the PSIM program, including protocol authorship, execution and planning oversight,
management of annual qualifications, and support for sterility investigations.* Drive skills development initiatives, including onboarding strategies, COE/consortium participation, and establishment and maintenance of competency and improvement trackers.* Collaborate with Production, QA, and cross-functional teams to support compliance initiatives, continuous improvement efforts, and evaluation of new technologies.* Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 7+ years relevant experience* Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 5+ years of relevant experience, or a* PhD degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 2+ years of relevant experience.* Excellent interpersonal and communication skills, both written and oral.* Proven competencies in drug product aseptic processing, equipment, and aseptic technique.* Experience in change management and leading quality investigations.* Familiarity with United States and European Union regulatory requirements and Safety compliance regulations.* Lean Six Sigma and Root Cause Analysis experience* Ability to author Standard Operating Procedures (SOP) and other GxP documents.* Experience with quality systems.* Excellent organizational skills.* Desire and willingness to learn, contribute, and lead.* Track-record of independent problem-solving.* Experience with C&Q, facility start-up, media fills, environmental monitoring programs, and readiness for aseptic operations.* Lean Six Sigma Certification* Teamwork and people development skills**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance #J-18808-Ljbffr
**Reports to:** FLEx Sterile Compliance Lead, Pharmaceutical Operations & Clinical Supply* Lead the development, maintenance, and assignment of training curricula, ensuring content remains current, relevant, and aligned with compliance requirements.* Monitor, track, and report on training completion, effectiveness, and adoption of training technologies, supporting continuous improvement.* Monitor the facility's environmental monitoring (EM) program, including data review, investigations, and execution of risk assessments to maintain compliance.* Support inspection readiness and participate in internal and external audits, including GMP compliance audits and Safety/GMP walkthroughs.* Review and assess evolving Quality Management System (QMS) documentation and procedures, assessing facility alignment with regulatory and internal requirements.* Manage SOP governance, including periodic reviews and updates driven by quality or operational changes.* Provide oversight for departmental investigations and change controls, ensuring timely closure, robust root‑cause analysis, effective action plans and CAPAs, and trend monitoring.* Oversight and further establishment of the facility Aseptic Observer Program, performing observations, data mining, CAPA development, and cross‑functional communication of results.* Lead operational responsibilities for the PSIM program, including protocol authorship, execution and planning oversight,
management of annual qualifications, and support for sterility investigations.* Drive skills development initiatives, including onboarding strategies, COE/consortium participation, and establishment and maintenance of competency and improvement trackers.* Collaborate with Production, QA, and cross-functional teams to support compliance initiatives, continuous improvement efforts, and evaluation of new technologies.* Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 7+ years relevant experience* Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 5+ years of relevant experience, or a* PhD degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 2+ years of relevant experience.* Excellent interpersonal and communication skills, both written and oral.* Proven competencies in drug product aseptic processing, equipment, and aseptic technique.* Experience in change management and leading quality investigations.* Familiarity with United States and European Union regulatory requirements and Safety compliance regulations.* Lean Six Sigma and Root Cause Analysis experience* Ability to author Standard Operating Procedures (SOP) and other GxP documents.* Experience with quality systems.* Excellent organizational skills.* Desire and willingness to learn, contribute, and lead.* Track-record of independent problem-solving.* Experience with C&Q, facility start-up, media fills, environmental monitoring programs, and readiness for aseptic operations.* Lean Six Sigma Certification* Teamwork and people development skills**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance #J-18808-Ljbffr