6556-Subject Matter Expert - Combination Products Quality & Compliance Lead GxP Auditor

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Phase 1 – Presentation Development (approx. 90 hours)

• →Lead a kickoff meeting with Client stakeholders to understand organizational needs and training objectives.
• →Capture the risks identified during assessments and interviews, along with key elements of the proposed future state, to keep the content focused and relevant.
• →Review Client's combination product processes and applicable quality system requirements.
• →Develop a customized Quality & Compliance Lunch and Learn presentation that incorporates key standards and industry best practices.
• →Work with business unit quality and compliance stakeholders to make sure topics, risks, and regulatory requirements are adequately covered, and get Client's approval before delivery.

Phase 2 – Training Delivery (approx. 4 hours)

• →Travel to Client and deliver the approved presentation on-site, with a simultaneous remote option through Microsoft Teams.
• →Support recording of the session for people who cannot attend.
• →Lead a question-and-answer session after the presentation.
• →Provide electronic copies of the final training materials to the client.

Phase 3 – Post-Training Support (approx. 60 hours)

• →Answer follow-up questions from Client process owners and stakeholders.
• →Provide ongoing SME guidance on combination product regulatory requirements and quality system expectations.
• →Clarify process owner roles, responsibilities, and documentation expectations as questions come up during implementation.
• →Refine and update training content based on feedback received.
• →Lead follow-up remote sessions as requested to reinforce key quality and compliance considerations.

Required

• →Bachelor's degree in a life science, engineering, or related technical field.
• →10+ years of experience in quality assurance, regulatory compliance, or auditing in the pharmaceutical, medical device, or combination product industries.
• →Proven experience as a lead GxP auditor, including audit program development and execution.
• →Deep working knowledge of combination product regulations and drug and device quality system requirements.
• →Familiarity with global regulatory frameworks (FDA, EMA, MHRA, Health Canada, PMDA, MFDS, TGA, Medsafe).
• →Demonstrated experience developing and delivering training to technical and cross-functional audiences.
• →Strong presentation, facilitation, and stakeholder communication skills.
• →Able to travel to client sites as required.

Preferred

• →Advanced degree in a relevant discipline.
• →Professional certification such as ASQ CQA, CQE, or RAC.
• →Experience supporting inspection readiness and regulatory inspections.
• →Consulting experience in client-facing, time-and-material engagements.