cGMP Training Program Lead

Job Summary

The cGMP Training Lead owns the site’s GxP Training Program strategy and roadmap, ensuring full alignment with corporate Quality Policy, global standards, and applicable regulatory requirements. This role provides program‑level leadership, driving the design, implementation, and continual improvement of risk‑based GxP curricula across the site.

Serving as the site’s Training Program Owner, the Lead collaborates cross‑functionally with Quality, Manufacturing, QC, HR and IT to ensure training effectiveness, inspection readiness, and consistency with global best practices. The role acts as the primary training SME during regulatory and customer audits, presenting program strategy, metrics, and compliance status.

Area Of Responsibility

• Owns and maintains the Site GxP Training Strategy and multi‑year roadmap in alignment with corporate Quality and Compliance objectives.
• Designs risk‑based GxP curricula by role/function, incorporating CAPA trends, deviation themes, human error analyses, and change control requirements.
• Establishes and oversees training governance, ensuring consistency with corporate standards and evolving regulatory expectations.
• Chairs the Site Training Governance Forum, driving harmonization across departments.
• Approves role-based curricula, training frequencies, waivers, and temporary deviations.
• Serves as the central decision-maker for training policy interpretation and updates.
• Functions as the Training Track Owner for regulatory agency inspections, customer audits, and corporate assessments.
• Leads creation of audit readiness plans, SME preparation, and supporting documentation.
• Presents training effectiveness, compliance metrics, and program design directly to FDA, notified bodies, and customer auditors.
• Defines and monitors KPIs for training compliance, training effectiveness, curriculum alignment, and reduction of human‑error deviations.
• Implements multi‑layered training effectiveness checks (e.g., knowledge assessments, observation, process performance indicators).
• Drives process improvements and long-term capability building across the site.
• Owns design of LMS and EDMS training workflows, ensuring compliance and efficient training processes.
• Defines the training data model, reporting structure, dashboards, and analytics for the site’s training                           program.
• Sponsors enhancements and works closely with corporate system owners, IT, and Quality Systems.
• Ensures adherence to global expectations for instructor competency and documentation.
• Ensures timely delivery of all required annual GxP training (e.g., cGMP, GDP, HIPAA, and other GxP topics).
• Oversees onboarding requirements and ensures training elements support inspection‑readiness for all new hires.

Ensures training content is current, risk‑appropriate, and reflective of regulatory updates.

Work Conditions:

• Office area
• Manufacturing floor
• Labs
• Warehouse

Physical Requirements:

• Sit, stand, walk, use hands and fingers to handle or feel, talk, hear, stoop, kneel, crouch or crawl
• Lift up to 25 lbs.
• Close  vision
• Gowning, lab coat, safety glasses, gloves in clean room areas
• Operate computer/office machines

Travel Estimate

• Up to 5%

Education and Job Qualification

• Bachelor’s degree required; Master’s preferred.
• 10+ years experience in regulated life sciences, including 5+ years of GxP training leadership or program ownership.
• Demonstrated ability to influence and lead cross‑functional teams without direct authority.
• Strong public speaking and regulatory‑facing communication skills; must be able to present program design, metrics, and inspection readiness narratives to regulators.
• Excellent organizational, planning, and prioritization skills.
• Ability to operate independently, applying judgment in ambiguous situations.
• Proficiency in MS Office, MasterControl, TrackWise, and other Quality systems.

Experience

• 10+ years of related experience in life science’ with 5+ years in GxP training leadership/program ownership
• Preferred certifications: ASQ CQA, ISO 13485 Lead auditor, or equivalent
• Working knowledge of cGMPs and ISO Standards
• Experience with administration of Learning Management Systems (LMS), Electronic Document Management System (EDMS) required, experience with Master Control, and LinkedIn learning is a plus.
• Strong sense of judgement and ability to act independently to solve problems and suggest solutions within their sphere of influence.
• Working knowledge of 21 CFR Parts 210, 211, 820ISO 13485, Aseptic training experience is a plus
• Work requires a sense of urgency and a “customer first” approach
• Experience presenting systems details to FDA or other notified bodies during audits.
• Instructor -led training experience required.
• Must have excellent computer skills, including MS Word, PowerPoint, Excel, TrackWise, and MasterControl.