Clinical Quality Auditor

Our client is a patient-driven cardiovascular biotechnology company dedicated to advancing heart disease treatment by developing therapies that address the root causes of disease rather than managing symptoms alone. Title: GCP Auditor Location: Hybrid (3 days onsite, South San Francisco, CA) Pay rate: $60-75hr+ Depends on experience Schedule: Full-time, M-F 8am-5pm Contract-to-hire We are seeking a GxP Auditor to join a quality team in a contract-to-hire capacity. This role is ideal for a seasoned auditor with strong GMP experience who is looking to contribute to a growing organization while supporting and helping scale a global audit program. Role Overview The GxP Auditor will be responsible for executing and supporting audits across internal operations, vendors, and investigator sites, ensuring compliance with global regulatory standards. This individual will also play a key role in strengthening audit program infrastructure, supporting audit reporting, and managing CAPA lifecycle activities. Key ResponsibilitiesPlan and conduct GxP audits (primarily GMP), including vendor and clinical/investigator site auditsPerform audit report reviews and ensure alignment with regulatory and quality standardsSupport the audit lifecycle, including CAPA review, approval, and closureContribute to the development and improvement of audit program infrastructureCollaborate cross-functionally with Quality and Operations teamsParticipate in scheduled audits across multiple regions (domestic and some international travel)Support upcoming GCP audits and ongoing audit planning activitiesTravel: 20-50% QualificationsMUST be a Certified Auditor (required)5-10+ years of experience in Quality, Compliance, or GxP auditing/inspectionsStrong working knowledge of FDA, EMA, ICH, and GMDP regulationsHands-on experience conducting GMP audits (vendor and/or clinical site audits preferred)Experience reviewing audit reports and managing CAPAsBachelor's or advanced degree in Life Sciences, Pharmacy, Chemistry, or related fieldExperience in biotech/pharma environments PreferredExperience with MHRA and Health Canada regulationsFamiliarity with Veeva and/or SmartsheetsStrong communication, collaboration, and stakeholder management skills INDBH #LI-MG1