Senior Supplier Quality Auditor

Role: Senior Supplier Quality Auditor responsible for planning, executing, and reporting supplier and external service provider audits to ensure compliance with cGMP/GxP regulations, internal SOPs, and quality agreements. Responsibilities include evaluating supplier compliance with regulatory standards (e.g., FDA, EMA, ICH), documenting audit findings, developing CAPAs, tracking closure, supporting inspection readiness, and providing guidance on GxP compliance. The role involves both onsite and remote audits with domestic travel required. Qualifications: Bachelor’s in Life Sciences, Chemistry, or related field; minimum of 7 years in quality assurance, auditing, or supplier management within biotech/pharma; at least 3 years of regulated GxP auditing experience; strong knowledge of global GxP regulations; proven ability to identify systemic risks and communicate effectively. Preferred skills include technical writing, stakeholder management, and leveraging AI tools to enhance productivity. High-value biopharma specifics: focus on supplier oversight within FDA, EMA, and ICH-regulated environments, supporting manufacturing quality assurance and regulatory inspection activities. The position is remote in the United States, with competitive compensation and benefits.