Position Summary Verista is looking for an experienced Senior Subject Matter Expert (SME) to act as Lead GxP Auditor on a client engagement with Client. The SME will design, deliver, and support a custom Lunch and Learn training on combination products for Client process owners. The training covers applicable regulatory requirements, quality system expectations, process owner responsibilities, and key compliance considerations. Its goals are to raise awareness, clarify who owns what, and support consistent execution across business processes.

Key Responsibilities

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.

Training Content Expertise The SME must be able to speak with authority on the following topics:

• Combination product regulatory overview, including 21 CFR Part 4
• Regulatory requirements mapped across FDA, EMA, MHRA, Health Canada, PMDA, MFDS, TGA, and Medsafe
• Integration of drug (cGMP) and device (QMSR / ISO 13485) quality system requirements
• Process owner roles and responsibilities
• Key quality system elements that affect combination products
• Documentation and data integrity expectations
• Change control and risk management (e.g., ISO 14971)
• Common compliance risks and inspection focus areas

Qualifications

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.

What We Offer

• The chance to shape quality and compliance practices at a leading medical technology company.
• Flexible, mostly remote work with focused on-site engagement.
• Collaboration with Verista's Regulatory, Compliance, and Product Lifecycle Management service line.