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

Portage, MI

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision‑making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world‑class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• 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

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…