Director of Quality

Director of Quality — Pharmaceutical Manufacturing Position Type: Full-Time Work Schedule: Onsite Industry: Pharmaceutical Manufacturing Function: Quality Assurance / Quality Control Leadership Position Summary: The Director of Quality provides strategic and operational leadership for all Quality Assurance and Quality Control activities at an FDA-regulated pharmaceutical manufacturing site. The role oversees development, implementation, and maintenance of a compliant cGMP Quality Management System supporting commercial liquid and solid dose production. This position serves as the sites primary quality authority and regulatory representative. Responsibilities: Lead site Quality Assurance and Quality Control organizations Maintain Quality Management System compliant with 21 CFR 210/211 Final approval authority for batch disposition and product release Manage: Deviations & investigations CAPA programs Change control Complaint handling Support regulatory inspections and audits as lead quality representative Ensure ongoing inspection readiness Partner with Manufacturing, Technical Operations, and Executive Leadership Qualifications: Bachelors degree in Life Sciences or related field (advanced degree preferred) 10+ years pharmaceutical manufacturing quality experience Prior leadership responsibility over QA and QC teams Strong working knowledge of FDA regulations and cGMP requirements Experience in commercial manufacturing environments Demonstrated regulatory inspection leadership Additional Information: Onsite leadership role Reports to senior executive leadership Opportunity within a stable, long-standing manufacturing organization