layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Subject Matter Expert - Combination Products Quality & Compliance Lead GxP Auditor at Verista, Inc.

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

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

Employer job description

Company Culture Guidelines & Values:

Key Responsibilities

Qualifications

What We Offer

Benefits

Equal opportunity and accommodations

About this listing

Listing check

Similar jobs

Similar jobs