A well-established pharmaceutical manufacturing organization is seeking a Director of Quality to lead all Quality Assurance and Quality Control functions at a U.S.-based FDA-regulated manufacturing site. This role is responsible for designing, implementing, and maintaining a compliant cGMP Quality Management System in accordance with 21 CFR 210/211, ensuring a sustained state of control across liquid and solid dose manufacturing operations. The Director of Quality will serve as the final authority for batch record review and product release, oversee deviation investigations, CAPAs, change control, and complaint handling, and act as the primary quality representative during regulatory inspections.
The ideal candidate brings 10+ years of pharmaceutical manufacturing quality experience with demonstrated leadership over both QA and QC teams in a commercial environment. This position requires deep expertise in FDA regulations, inspection readiness, and quality systems governance, along with the ability to operate independently and partner closely with operations, scientific, and executive leadership. The role is onsite and offers the opportunity to make a meaningful impact within a stable manufacturing organization with a long operational history and strong commitment to regulatory compliance.
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