Senior Manager / Associate Director, GCP Quality Assurance Consultant

Senior Manager / Associate Director, GCP Quality Assurance Consultant RegDev San Diego, CA Job Details 1 hour ago Qualifications Regulatory inspections Pharmaceutical regulatory compliance Writing skills Quality management Quality assurance audits ICH guidelines Clinical research compliance Research regulatory compliance Full Job Description We are seeking an experienced GCP QA Auditor Consultant to support activities for RegDev, Inc.'s quality assurance team by conducting internal and external audits in compliance with applicable regulations and Good Clinical Practice (GCP). Summary of Job We are seeking an experienced GCP QA Auditor Consultant to support activities for RegDev, Inc.'s quality assurance team by conducting internal and external audits in compliance with applicable regulations and Good Clinical Practice (GCP). The consultant will assess quality systems, ensure regulatory compliance, and recommend improvements to meet industry standards and regulatory expectations (FDA, EMA, MHRA, etc.). This position is remote. Essential Duties and Responsibilities Perform and complete audit reports for RegDev, Inc. clients and work with the internal Project Leader(s) to ensure accuracy and timely completion of audits and reports. Audits may include both internal audit of Sponsors and supplier audits for clients. Plan, schedule, and conduct GCP audits of internal departments at Sponsor organizations, and suppliers such as contract research organizations. Evaluate compliance with applicable regulations (21 CFR, EU Clinical Trial Regulation (CTR), ICH E and Q-series, etc.) and internal SOPs. Prepare detailed audit plans, conduct audits, and generate comprehensive audit reports. Identify quality and compliance gaps, assess risk, and provide practical recommendations for improvement. Support regulatory inspection readiness and mock inspections. Collaborate with cross-functional teams to follow up on audit findings and CAPA implementation. Provide guidance and training on regulatory compliance, ICH GCP E6 status and implementation, and auditing best practices. Maintain audit schedules, logs, and audit-related documentation. Stay current with regulatory changes and industry best practices.

Job Requirements Education:

Bachelor's or Master's degree in Life Sciences, Pharmacy, Chemistry, or a related field.

Experience:

Minimum 10-15 years of experience in GCP auditing. In-depth knowledge of US, EU, and UK clinical trial regulations, ICH E6 Good Clinical Practices, and quality systems. Certified GCP Auditor (e.g.

ASQ) encouraged. Strong report-writing, communication, and interpersonal skills. Ability to work independently and manage multiple audits or projects.

Other Skills and Abilities:

Experience with data integrity auditing. Knowledge of electronic quality management systems (eQMS) and audit management tools. Regulatory inspection experience (FDA, EMA, etc.) is a plus. Strong interpersonal, written and verbal communication and team building skills required. Must be independent, self-starter. ADA Notations Ability to sit for long periods of time, handling, feeling with hands, reaching with arms. Regular communication (hearing/speaking). Willingness to travel domestically and internationally; overnight travel required as needed. Lifting up to 25 lbs. Routine home and onsite office duties including computer keyboard use. Vision requirements include close vision and ability to focus. Noise conditions range from quiet to moderate - home office conditions variable.

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