Key Responsibilities:
Lead and manage the Quality Assurance department including quality systems document control and compliance functions.
Serve as the companys 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.
Qualifications :
Required:
Bachelors 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
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Full-time
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