Director Quality Assurance & Compliance

Overview I’m currently partnered with a fast-growing pharmaceutical company on a retained search. They’re committed to delivering high-quality, innovative healthcare solutions. With deep expertise across sterile, topical, and combination product platforms, they support both their own product portfolio and client-based development efforts—bringing life-changing therapies to market. They’re seeking an experienced candidate to own and evolve the Quality Management System (QMS) across internal operations and external partners, as well as supporting audits, inspections and supplier quality. Key responsibilities Lead the design, implementation, and continuous improvement of the QMS to meet FDA and global regulatory expectations Establish robust quality processes to enhance efficiency, reduce risk, and ensure inspection readiness Oversee the implementation and management of an electronic QMS (e.g., Qualio, DocuSign, TraceLink) Direct internal audit planning, execution, and CAPA management Build and lead the Supplier Quality team and processes Serve as the company’s lead during regulatory inspections and audit readiness efforts Manage document control for SOPs, specifications, batch records, and protocols Ensure timely initiation and closure of quality records, deviations, and change controls Oversee corporate GMP training and evaluate program effectiveness Facilitate Management Review meetings and Annual Product Quality Reviews (APQRs) Qualifications and experience Degree in relevant field 8 years of experience in FDA-regulated pharmaceutical or biotech environments Experience in pharmaceuticals Strong working knowledge of cGMPs Proven leadership in regulatory inspection preparedness and eQMS implementation Experience with audits and inspections Strong communicator and collaborator who thrives in fast-paced, high-growth settings Apply today to learn more, or reach out directly to rbanton@barringtonjames.com J-18808-Ljbffr