Senior Manager GD GCP Auditing

For our client, we are seeking a Senior Manager GD GCP Auditing to join the team of a leader in the Pharmaceuticals & Biotech space. This role will lead global Good Clinical Practice auditing activities that help ensure clinical research operations remain compliant, inspection-ready, and aligned with evolving regulatory expectations. You will oversee a risk-based audit program spanning studies, sites, vendors, and partners, with significant interaction across Quality Assurance, clinical teams, and senior leadership. The position requires a strong command of FDA, EU, and ICH requirements, along with the ability to translate complex policies into practical compliance actions. The work will have direct impact on audit quality, issue resolution, and the organization’s readiness for regulatory inspections. Location: Remote - US based candidates only, no visa sponsorship available Compensation: $134,400 – $219,200 annually Responsibilities Lead end-to-end GCP audits across global activities Schedule, conduct, report, and follow up on audits Develop and execute risk-based audit programs for clinical studies Identify compliance issues and drive process improvements Represent Quality Assurance on complex compliance projects Interpret policies and regulations to address critical issues Support regulatory inspections and related activities Qualifications Bachelor’s degree with 8+ years of relevant industry experience; Master’s degree preferred Minimum 5 years of direct GCP audit experience Expert knowledge of FDA and EU regulations, ICH guidance, and GCP requirements Experience conducting process, site, vendor, and partner audits Experience with regulatory inspections involving investigator sites, sponsors, or CROs Strong leadership skills with experience interfacing with senior leaders Excellent project and stakeholder management skills Benefits Remote work model allowing flexibility in work location Opportunity to work on complex compliance projects Build trusted relationships with stakeholders across global teams Engagement in dynamic and evolving work environments Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.