cGMP Training Program Lead

Responsibilities

• Own and maintain the site’s GxP Training Strategy and multi-year roadmap in alignment with corporate Quality and Compliance objectives.
• Design risk-based GxP curricula by role and function, incorporating CAPA trends, deviation themes, and change control requirements.
• Serve as the primary Training Subject Matter Expert (SME) during regulatory agency inspections, customer audits, and corporate assessments.
• Define and monitor KPIs for training compliance, effectiveness, and the reduction of human-error deviations.
• Oversee the design of LMS and EDMS training workflows to ensure compliance and efficient processes.
• Lead the creation of audit readiness plans and present training metrics directly to the FDA and other notified bodies.
• Ensure timely delivery of all required annual GxP training, including cGMP, GDP, and HIPAA.

Requirements

• Bachelor’s degree required (Master’s degree preferred).
• 10+ years of experience in regulated life sciences.
• 5+ years of GxP training leadership or program ownership experience.
• Proficiency in MS Office, MasterControl, and TrackWise.
• Strong public speaking and regulatory-facing communication skills.
• Demonstrated ability to lead cross-functional teams and operate independently in ambiguous situations.

Preferred Qualifications

• Professional certifications such as ASQ CQA or ISO 13485 Lead Auditor.
• Working knowledge of 21 CFR Parts 210, 211, and 820.
• Experience with Learning Management Systems (LMS) and Electronic Document Management Systems (EDMS).
• Experience with aseptic training and instructor-led training delivery.

Benefits

• Competitive compensation with incentive programs.
• Comprehensive health and wellness benefits including medical, dental, and vision.
• Support for career growth and professional development.
• Paid time off and leave-of-absence options.
• 401(k) savings plan and flexible spending accounts.

About the Company

Sun Pharma is a global pharmaceutical company dedicated to meeting and exceeding the quality standards that medical professionals and patients expect. We foster a safe, clean, and regulated work environment rooted in transparency, collaboration, and continuous learning.