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

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.

Responsibilities

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; 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; 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; 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; Refine and update training content based on feedback received; Lead follow-up remote sessions as requested to reinforce key quality and compliance considerations

Requirements

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

Nice to have

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

Benefits

High growth potential and fast-paced organization with a people-focused culture; Competitive pay plus performance-based incentive programs; Company-paid Life, Short-Term, and Long-Term Disability Insurance; Medical, Dental & Vision insurances; FSA, DCARE, Commuter Benefits; Supplemental Life, Hospital, Critical Illness and Legal Insurance; Health Savings Account; 401(k) Retirement Plan (Employer Matching benefit); Paid Time Off (Rollover Option) and Holidays; As Needed Sick Time; Tuition Reimbursement; Team Social Activities; Employee Recognition; Employee Referral Program; Paid Parental Leave and Bereavement