Sr. Clinical QA Auditor
About The Position
MCRA is part of IQVIA MedTech. As a trusted CRO and advisory partner, IQVIA MedTech and MCRA deliver integrated lifecycle solutions for the medical device and diagnostics industry. Together, we support innovation from concept to commercialization, offering expertise in regulatory strategy, clinical trial design and execution, market access, and post-market optimization. Our teams combine deep therapeutic knowledge with advanced data and technology to help clients make smarter decisions and thrive in the market. Join our team to help shape the future of MedTech. Overview The Sr. Clinical QA Auditor is a critical CQA team member. We are seeking an experienced Senior Clinical QA Auditor to support and lead quality assurance activities across clinical trials within a fast-paced CRO environment. This individual will serve as a subject matter expert in GCP compliance, driving audit strategy, inspection readiness, and continuous quality improvement across sponsors, sites, and internal processes.
Requirements
- Bachelor’s degree
- 5–10 years of experience in clinical quality assurance, auditing, or clinical operations within a CRO, pharma, or biotech environment.
- Medical device experience required
- Experience or exposure to global GCP regulations required
- Excellent oral and written communication skills and presentation skills
- Familiarity with the Quality Management System including (but not limited to): quality training, data management, computer system validation, document control, change control, audits and inspections, quality issues and CAPA, vendor management, regulatory compliance, and all areas of GCP.
- Proficient in all MS Office applications, including Outlook and Teams.
- Demonstrated professional oral and written communications.
- Ability to read, write, speak, and understand English fluently is required.
Nice To Haves
- Familiarity with ISO standards and EU GDPR regulations preferred.
- Experience in process improvement and project management preferred.
- Strong working knowledge of eQMS, EDC, eTMF, Document Management and SaaS systems preferred.
Responsibilities
- Lead and execute GCP audits including investigator sites, vendors, internal systems, and sponsor audits
- Plan, conduct, and report onsite and remote audits, ensuring alignment with regulatory requirements (FDA, EMA, ICH-GCP)
- Design and lead mock FDA/EMA inspections and inspection readiness initiatives for sponsors and clinical sites
- Provide onsite audit support during regulatory inspections, including hosting, documentation, and response coordination
- Provide support and guidance on GCP regulations and quality improvement initiatives.
- Perform and oversee TMF quality reviews and audits, ensuring completeness, accuracy, and inspection readiness
- Identify compliance risks, trends, and gaps
- Act as a trusted advisor to sponsors, providing strategic input on quality systems and regulatory expectations
- Contribute to the development and continuous improvement of QA processes, SOPs, and audit methodologies
- Participate in review of internal and external Quality Issues (QIs) and Corrective and Preventive Action (CAPA) plans.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
