Senior Quality Assurance Associate - GMP/GDP Auditing

Role: Senior Quality Assurance Associate focusing on GMP/GDP audits within a biotech environment dedicated to rare diseases. Primary objectives include executing risk-based audits of external suppliers, ensuring compliance with global regulatory standards (FDA, EU, ICH, ISO), and supporting inspection readiness. Responsibilities encompass planning and conducting onsite, remote, and hybrid audits; reviewing supplier documentation and CAPA plans; managing supplier qualification and performance monitoring; and contributing to quality system enhancements and regulatory inspections. Requirements: Bachelor’s degree in Life Sciences, Engineering, or related field; 5+ years of QA experience in FDA-regulated industries; 3+ years of GMP/GDP auditing experience; familiarity with pharmaceutical, biologic, or medical device audits; and experience with electronic Quality Management Systems (preferably Veeva Vault). Preferred qualifications include Lead Auditor certification and extensive knowledge of U.S. and EU GMP/GDP regulations. High-value specifics: focus on supplier audits, risk management, and compliance oversight for biologics or small-molecule therapies in late clinical or commercial stages. Role involves cross-functional collaboration with Technical Operations, Regulatory Affairs, and Clinical teams; the position is remote-based with domestic and international travel (25-40%).