Sr Manager, Training

Emergent Biosolutions•Canton, MA

3d•$150,000 - $181,500

About The Position

The Sr. Manager, Training is a senior Quality leadership role accountable for the end-to-end governance, effectiveness, and continuous improvement of the GMP Training program at the Canton, MA GMP vaccine Drug Substance (DS) manufacturing site. The role ensures site compliance with applicable U.S. and international GxP regulations, Emergent Global Quality Standards, and regulatory expectations (e.g., FDA, EMA). This position serves as the site owner for the Learning Management System (LMS/eLM), with direct responsibility for training program strategy, inspection readiness, and data integrity. The incumbent partners closely with Global Process Owners (GPOs) for Training and related Quality systems to ensure consistent global-to-site deployment, effective implementation of system upgrades, and alignment with evolving regulatory and business needs. The Sr. Manager acts as a key Quality representative for internal and external audits, and supports site leadership by providing actionable KPIs, risk-based insights, and strategic recommendations to sustain a Compliant, inspection-ready, and agile Quality system.

Requirements

Bachelor’s degree in Life Sciences, Education, Engineering, or a related scientific discipline required.
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
Demonstrated experience administering and governing LMS/eLM platforms in a GMP environment.
Proven experience supporting regulatory inspections (e.g., 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.
High level of personal integrity, sound judgment, accountability, and commitment to quality culture.

Nice To Haves

Master’s degree or advanced certification in Quality, Regulatory, Instructional Design, or Business Management preferred.

Responsibilities

Own, manage, and continuously improve the site GMP Training Program in alignment with regulatory expectations, Global Standards, and site operations.
Serve as Site Process Owner (SPO) for LMS/eLM, including system configuration, administration, governance, change management, user access, and data integrity oversight.
Ensure periodic GMP training, role-based qualification, and personnel competency programs are implemented, maintained, and inspection-ready in accordance with CGMP and internal procedures.
Approve GMP training materials and ensure training content is technically accurate, risk-based, and appropriate for adult learners, including instructor-led training, OJT, and electronic learning.
Partner with Global Process Owners (GPOs) to deploy global processes, system enhancements, integrations, and performance metrics at the site while managing site-specific impacts and regulatory risks.
Establish, monitor, and report meaningful KPIs and effectiveness metrics for training compliance, qualification status, document lifecycle performance, and inspection readiness.
Lead gap assessments, root cause evaluations, and CAPAs related to training; ensure timely and sustainable remediation.
Ensure job descriptions, curricula, qualifications, and CVs are maintained within employee electronic training records in compliance with regulatory and internal requirements.
Act as a primary Quality contact for client, internal, and regulatory inspections impacting training systems; participate in inspection preparation, execution, response, and follow-up.
Drive continuous improvement initiatives leveraging risk management principles (ICH Q9) and Quality system maturity concepts (ICH Q10).
Build organizational capability through mentoring, technical development, and cross-functional collaboration.
Proactively identify resource needs and advocate for investments required to sustain compliant and scalable systems.
Partner with site and Quality leadership to embed Quality culture, accountability, and compliance into daily operations.