Quality Assurance Consultant

The Senior GCP Auditor is a highly autonomous, self‑driven quality professional responsible for assuring compliance with global regulatory requirements across outsourced partners and, where required, clinical investigative sites. This role has a strong emphasis on vendor audits and plays a critical role in regulatory inspection readiness, supporting and leading preparedness activities for FDA, EMA, and MHRA inspections.

The successful candidate will operate independently, demonstrate sound regulatory judgment, and act as a trusted quality advisor to internal stakeholders, ensuring sustained inspection readiness and continuous compliance across GxP activities.

• Independently plan, lead, and conduct vendor audits (qualification, routine, risk‑based, and for‑cause) of:
• CROs
• Central and specialty laboratories
• Data management, pharmacovigilance, and other critical service providers
• Conduct clinical investigative site audits to evaluate adherence to GCP, protocol requirements, and applicable regulations.
• Apply a risk‑based auditing approach, focusing on critical processes, data integrity, and patient safety.

• Play a lead role in maintaining continuous inspection readiness for FDA, EMA, MHRA, and other global health authorities.
• Support and prepare internal teams and vendors for regulatory inspections, including:
• Readiness assessments and gap analyses
• Mock inspections and rehearsal interviews
• Inspection response planning and coordination
• Review and assess inspection outcomes, ensuring timely, compliant responses and follow‑up actions.
• Act as a subject matter expert during live regulatory inspections as required.

• Interpret and apply global regulatory requirements and guidance, including:
• ICH GCP (E6)
• OECD GLP
• GCLP guidelines
• FDA, EMA, MHRA regulations and expectations
• Provide clear, practical compliance guidance to internal functions and external partners.

• Author high‑quality audit reports that clearly articulate observations, root causes, and risk impact.
• Review, challenge, and approve CAPA plans to ensure they are:
• Root‑cause driven
• Sustainable
• Regulatory‑compliant
• Track audit and inspection findings to closure and verify CAPA effectiveness.

• Partner closely with Clinical Operations, Regulatory Affairs, Vendor Management, and Laboratory functions.
• Support vendor qualification, selection, and ongoing oversight activities.
• Represent Quality Assurance in cross‑functional forums and inspection readiness initiatives.
• Contribute to the development and enhancement of QA SOPs, audit strategies, and inspection readiness frameworks.
• Monitor regulatory trends and inspection findings to proactively mitigate compliance risks.
• Champion a culture of quality, accountability, and continuous improvement.

• Bachelor’s degree in Life Sciences, Pharmacy, Medicine, Nursing, Laboratory Sciences, or related discipline (advanced degree preferred).

• 10+ years of experience in GxP Quality Assurance and auditing.
• Proven experience conducting vendor audits in clinical research and/or laboratory environments.
• Demonstrated experience auditing clinical investigative sites.
• Direct experience supporting or leading activities related to FDA, EMA, and MHRA inspections.
• Strong background in inspection readiness and regulatory interaction.

• Certified Auditor qualification required, such as:
• ASQ Certified Quality Auditor (CQA), or
• Equivalent internationally recognized auditing certification.

• In‑depth knowledge of GCP, GLP, and GCLP.
• Strong understanding of FDA, EMA, and MHRA regulatory expectations.
• Excellent written and verbal communication skills, including confident engagement with regulators and senior stakeholders.
• Strong analytical and risk‑assessment capabilities.
• Exceptional organizational and time‑management skills.
• Ability to work independently as a self‑starter, managing multiple priorities with minimal supervision.
• Willingness to travel (typically 20–40%).

• Highly self‑motivated with a proactive, hands‑on approach.
• High integrity, objectivity, and professional judgment.
• Confident yet collaborative style when working with vendors and internal teams.
• Calm and effective under inspection pressure.