Sr. QA Specialist, Supplier Quality

The Sr. QA Specialist – Supplier Quality leads the qualification and ongoing quality oversight of third parties, including suppliers, service providers, and contract development and manufacturing organizations (CDMOs), and supports key quality system functions to ensure compliance with cGMP and regulatory standards in a biotech environment. With over five years of experience, this role manages complex investigations, oversees change control and CAPA processes, supports regulatory inspections, and mentors junior QA staff. The specialist drives continuous improvement and cross-functional collaboration to uphold product quality and operational excellence. Duties and Responsibilities (Responsibilities include but are not limited to): Lead risk-based qualification and requalification of third parties, including suppliers and service providers, through assessments, audits, and documented recommendations for approval. Manage ongoing third-party quality oversight, including performance monitoring, quality agreements, change notifications, and follow-up on quality issues and corrective actions. Maintain third-party qualification records and approved status, ensuring timely periodic reviews and escalation of quality and compliance risks. Manage contractors and consultants performing third-party audits, including audit scope, scheduling, and deliverable review; independently plan and conduct audits, prepare reports, and follow up on corrective actions. Lead and execute quality oversight