Sr Manager, Training
Emergent BioSolutions
5 hours ago
On-site
Canton, MA
Human Resources
Job Summary
Sr. Manager, Training is a senior Quality leadership role accountable for end-to-end governance, effectiveness, and continuous improvement of the GMP Training program at the Canton, MA GMP vaccine Drug Substance manufacturing site. Ensures compliance with applicable U.S. and international GxP regulations, Global Quality Standards, and regulatory expectations (e.g., FDA, EMA). Serves as site owner for the Learning Management System (LMS/eLM), with responsibility for training strategy, inspection readiness, and data integrity. Acts as a key Quality representative for audits.
Responsibilities
- Own, manage, and continuously improve the site GMP Training Program.
- Serve as Site Process Owner (SPO) for LMS/eLM (configuration, administration, governance, change management, user access, data integrity oversight).
- Ensure GMP training, role-based qualification, and competency programs are implemented and inspection-ready.
- Approve GMP training materials; ensure content is technically accurate, risk-based, and appropriate for adult learners.
- Partner with Global Process Owners to deploy global processes and enhancements while managing site impacts and risks.
- Establish and report KPIs/effectiveness metrics for training compliance, qualification, document lifecycle, and inspection readiness.
- Lead training-related gap assessments, root cause evaluations, and CAPAs.
- Maintain job descriptions, curricula, qualifications, and CVs within employee electronic training records.
- Support and respond to internal/client/regulatory inspections impacting training systems.
- Drive continuous improvement using ICH Q9/Q10 principles; mentor and build cross-functional capability.
Qualifications
- Bachelor’s degree in Life Sciences, Education, Engineering, or related scientific discipline (required).
- Master’s degree/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 GMP Training or Quality Systems experience.
- Experience administering/governing LMS/eLM in GMP environments.
- Proven experience supporting regulatory inspections (e.g., FDA, EMA) and remediation.
- Expert knowledge of GMP regulations, GDocP, and Quality Systems (21 CFR Parts 210/211; ICH Q7, Q9, Q10).
Skills/Competencies
- Strong analytical, written/verbal communication, leadership/influencing, and change management skills.
- Strong adult learning/instructional design and competency-based qualification knowledge.
- Integrity, sound judgment, accountability, and quality-culture commitment.
Benefits
- Comprehensive benefits package is offered (details via company careers site).
Application Instructions
- If selected for an interview, speak with an HR Partner about compensation philosophy and available benefits.
Sr. Manager, Training is a senior Quality leadership role accountable for end-to-end governance, effectiveness, and continuous improvement of the GMP Training program at the Canton, MA GMP vaccine Drug Substance manufacturing site. Ensures compliance with applicable U.S. and international GxP regulations, Global Quality Standards, and regulatory expectations (e.g., FDA, EMA). Serves as site owner for the Learning Management System (LMS/eLM), with responsibility for training strategy, inspection readiness, and data integrity. Acts as a key Quality representative for audits.
Responsibilities
- Own, manage, and continuously improve the site GMP Training Program.
- Serve as Site Process Owner (SPO) for LMS/eLM (configuration, administration, governance, change management, user access, data integrity oversight).
- Ensure GMP training, role-based qualification, and competency programs are implemented and inspection-ready.
- Approve GMP training materials; ensure content is technically accurate, risk-based, and appropriate for adult learners.
- Partner with Global Process Owners to deploy global processes and enhancements while managing site impacts and risks.
- Establish and report KPIs/effectiveness metrics for training compliance, qualification, document lifecycle, and inspection readiness.
- Lead training-related gap assessments, root cause evaluations, and CAPAs.
- Maintain job descriptions, curricula, qualifications, and CVs within employee electronic training records.
- Support and respond to internal/client/regulatory inspections impacting training systems.
- Drive continuous improvement using ICH Q9/Q10 principles; mentor and build cross-functional capability.
Qualifications
- Bachelor’s degree in Life Sciences, Education, Engineering, or related scientific discipline (required).
- Master’s degree/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 GMP Training or Quality Systems experience.
- Experience administering/governing LMS/eLM in GMP environments.
- Proven experience supporting regulatory inspections (e.g., FDA, EMA) and remediation.
- Expert knowledge of GMP regulations, GDocP, and Quality Systems (21 CFR Parts 210/211; ICH Q7, Q9, Q10).
Skills/Competencies
- Strong analytical, written/verbal communication, leadership/influencing, and change management skills.
- Strong adult learning/instructional design and competency-based qualification knowledge.
- Integrity, sound judgment, accountability, and quality-culture commitment.
Benefits
- Comprehensive benefits package is offered (details via company careers site).
Application Instructions
- If selected for an interview, speak with an HR Partner about compensation philosophy and available benefits.