Senior Quality Assurance Associate - GMP/GDP Auditing

Role: Senior Quality Assurance Associate specializing in GMP and GDP auditing within biopharma. Objectives include executing risk-based audits of external partners, supporting supplier qualification, and ensuring inspection readiness to maintain regulatory compliance. Responsibilities encompass conducting onsite, remote, and hybrid audits of contract manufacturing, testing labs, and logistics providers; preparing audit reports, tracking CAPAs, and reviewing supplier documentation and performance metrics. The role requires collaboration with Technical Operations, Supply Chain, Regulatory Affairs, and other teams. Qualifications: Bachelor’s in Life Sciences, Engineering, or related field; 5+ years QA experience in FDA-regulated environments; 3+ years GMP/GDP audit experience; familiarity with supplier oversight, regulatory inspections, and electronic QMS systems (Veeva Vault preferred). Preferred certifications include Lead Auditor (ASQ, IRCA, Exemplar Global). The role demands strong knowledge of U.S. and EU GMP/GDP regulations, excellent communication, and risk assessment skills. High-value biopharma specifics: focus on external supplier audits, qualification, and compliance in a rare disease setting, with an emphasis on GxP systems, inspection readiness, and cross-functional stakeholder engagement. Location: Remote, with 25-40% travel domestically and internationally.