The Director of Quality Assurance provides strategic leadership and direction for all aspects of Client's quality systems, compliance, and regulatory operations. This role ensures adherence to FDA, DEA, cGMP, and USP regulations while fostering a strong culture of quality across the organization.
Key Responsibilities:
Lead and manage the Quality Assurance department, including quality systems, document control, and compliance functions.
Serve as the company's primary quality authority for all cGMP-related matters, including product release and regulatory inspections.
Oversee batch review, deviation investigations, CAPA programs, and change controls.
Ensure adherence to 21 CFR Parts 210/211, USP <797> /<800> , and other applicable regulations.
Lead and support external audits, including FDA, DEA, and State Board of Pharmacy inspections.
Collaborate with Manufacturing, QC, Validation, and Regulatory Affairs to maintain compliance throughout the product lifecycle.
Review and approve SOPs, validation protocols, and quality-related documentation.
Establish and maintain an effective Quality Management System (QMS) and metrics tracking program.
Drive initiatives for continuous improvement and risk mitigation across quality processes.
Required:
Bachelor's degree in chemistry, Microbiology, Pharmacy, or related scientific field.
Minimum 10+ years of progressive Quality Assurance experience in pharmaceutical manufacturing, with at least 5 years in sterile injectable or aseptic operations.
In-depth knowledge of FDA, cGMP, USP, and ICH guidelines.
Oversee batch review, deviation investigations, CAPA programs, and change controls.
Ensure adherence to 21 CFR Parts 210/211, USP <797> /<800> , and other applicable regulations.
Lead and support external audits, including FDA, DEA, and State Board of Pharmacy inspections
All your information will be kept confidential according to EEO guidelines.
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