Sr Manager, Training
Emergent BioSolutions
July 01, 2026
On-site
Canton, MA
Human Resources
Job Summary
- Sr. Manager, Training (Quality leadership) accountable for end-to-end governance, effectiveness, and continuous improvement of the GMP Training program at the Canton, MA GMP vaccine Drug Substance (DS) manufacturing site.
- Site owner for LMS/eLM, including training strategy, inspection readiness, and data integrity; partners with Global Process Owners (GPOs) to deploy and upgrade training systems.
- Supports internal/external audits; provides KPIs, risk-based insights, and recommendations to maintain a compliant, inspection-ready, agile Quality system.
Essential Functions / Responsibilities
- Own and continuously improve the site GMP Training Program (CGMP/Global Standards).
- Serve as Site Process Owner for LMS/eLM (configuration, governance, change management, user access, data integrity).
- Implement/maintain inspection-ready GMP training, role-based qualification, and competency programs.
- Approve training materials; ensure technically accurate, risk-based content suitable for adult learners (ILT, OJT, eLearning).
- Deploy global training processes and system enhancements; manage site-specific impacts/regulatory risks.
- Establish and report training effectiveness/compliance KPIs.
- Lead training-related gap assessments, root cause analyses, and CAPAs.
- Ensure job descriptions/curricula/qualifications/CVs are maintained in employee electronic training records.
- Act as primary Quality contact for client/internal/regulatory inspections impacting training; execute and close out follow-up.
- Drive continuous improvement using ICH Q9/Q10; mentor and develop teams; identify resource needs.
Minimum Education, Experience, Skills
- Bachelor’s degree in Life Sciences, Education, Engineering, or related scientific discipline (required).
- Master’s degree or advanced certification in Quality, Regulatory, Instructional Design, or Business Management (preferred).
- 8–10+ years in regulated biopharma/vaccine/biotech manufacturing with direct GMP accountability.
- 5+ years progressive experience in GMP Training or Quality Systems.
- Demonstrated experience administering/governing LMS/eLM in a GMP environment.
- Experience supporting FDA/EMA inspections and managing outcomes/remediation.
- Expert knowledge of GMP/GDocP and Quality Systems (21 CFR Parts 210/211; ICH Q7, Q9, Q10).
- Strong training/competency/adult learning and analytical, communication, and change leadership skills.
Benefits
- Comprehensive benefits package (eligibility governed by plan documents/policies).
- Sr. Manager, Training (Quality leadership) accountable for end-to-end governance, effectiveness, and continuous improvement of the GMP Training program at the Canton, MA GMP vaccine Drug Substance (DS) manufacturing site.
- Site owner for LMS/eLM, including training strategy, inspection readiness, and data integrity; partners with Global Process Owners (GPOs) to deploy and upgrade training systems.
- Supports internal/external audits; provides KPIs, risk-based insights, and recommendations to maintain a compliant, inspection-ready, agile Quality system.
Essential Functions / Responsibilities
- Own and continuously improve the site GMP Training Program (CGMP/Global Standards).
- Serve as Site Process Owner for LMS/eLM (configuration, governance, change management, user access, data integrity).
- Implement/maintain inspection-ready GMP training, role-based qualification, and competency programs.
- Approve training materials; ensure technically accurate, risk-based content suitable for adult learners (ILT, OJT, eLearning).
- Deploy global training processes and system enhancements; manage site-specific impacts/regulatory risks.
- Establish and report training effectiveness/compliance KPIs.
- Lead training-related gap assessments, root cause analyses, and CAPAs.
- Ensure job descriptions/curricula/qualifications/CVs are maintained in employee electronic training records.
- Act as primary Quality contact for client/internal/regulatory inspections impacting training; execute and close out follow-up.
- Drive continuous improvement using ICH Q9/Q10; mentor and develop teams; identify resource needs.
Minimum Education, Experience, Skills
- Bachelor’s degree in Life Sciences, Education, Engineering, or related scientific discipline (required).
- Master’s degree or advanced certification in Quality, Regulatory, Instructional Design, or Business Management (preferred).
- 8–10+ years in regulated biopharma/vaccine/biotech manufacturing with direct GMP accountability.
- 5+ years progressive experience in GMP Training or Quality Systems.
- Demonstrated experience administering/governing LMS/eLM in a GMP environment.
- Experience supporting FDA/EMA inspections and managing outcomes/remediation.
- Expert knowledge of GMP/GDocP and Quality Systems (21 CFR Parts 210/211; ICH Q7, Q9, Q10).
- Strong training/competency/adult learning and analytical, communication, and change leadership skills.
Benefits
- Comprehensive benefits package (eligibility governed by plan documents/policies).