Sr Manager, Training
$150,000–$181,500 year
On-site · Canton, Massachusetts, United States
Job Summary
Senior Quality leadership role owning the GMP Training program at the Canton, MA site; responsible for LMS/eLM governance, training strategy, inspection readiness, KPIs, data integrity, and CAPA management; collaborates with Global Process Owners to deploy global processes and standards; requires extensive GMP training/quality systems experience and demonstrated ability to support regulatory inspections; emphasizes instructional design, adult learning, and leadership in a regulated biopharmaceutical environment.
Required Qualifications
- Bachelor’s degree in Life Sciences, Education, Engineering, or a related scientific discipline required
- Master’s degree or advanced certification in Quality, Regulatory, Instructional Design, or Business Management preferred
- Minimum of 8–10 years of experience in a regulated biopharmaceutical, vaccine, or biotechnology manufacturing environment with direct GMP accountability
- Minimum of 5 years of progressive experience in GMP Training or Quality Systems
- Experience administering and governing LMS/eLM platforms in a GMP environment
- Proven experience supporting regulatory inspections (FDA, EMA) and managing inspection outcomes, including responses and remediation
- Experience partnering with global organizations and Global Process Owners to implement enterprise Quality systems and standards
- Expert knowledge of U.S. and international GMP regulations, GDocP, and Quality Systems (21 CFR Parts 210/211, ICH Q7, Q9, Q10)
- Strong understanding of GMP training principles, competency-based qualification, adult learning theory, and instructional design
- Strong analytical skills with the ability to interpret metrics, identify trends, and drive risk-based decisions
- Excellent written and verbal communication skills, with the ability to communicate effectively at all organizational levels, including senior leadership and regulators
- Proven leadership, influencing, and change management skills with a track record of fostering collaboration across Quality, Manufacturing, MSAT, and Engineering
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