Quality Assurance Officer (AD or Higher)

We are currently working with a pharmaceutical company engaged in developing, manufacturing, and marketing pharmaceutical products across generics and specialty drugs The client is seeking an Associate Director (or Higher) Quality officer to head out their Quality department as they are building a manufacturing site at their Sacramento branch.Key **í˜ Enforce GMP complianceí˜ Provide Quality and Compliance oversight of drug supply operationsí˜ Work closely with regulatory affairs department to ensure quality and compliance issues related to customer complaint, adverse events, quality events, market recalls, and pharmacovigilance reportingí˜ Prepare for FDA auditsí˜ Lead FDA auditsí˜ Perform 3rd party vendor audits. Vendors including contract manufacturing organization, 3rd party logistics, contract research organization, contract research laboratory, API manufacturer, raw material supplier, primary/secondary packaging material supplierí˜ Lead audits and interface with customers and regulatory representativesí˜ Perform vendor qualification for the API, raw material and primary/secondary finished goodsí˜ Draft, review and approve quality agreements between the company and contracted organizations including but not limited to contract manufacturer, contact lab etc.í˜ Review finished product certificate of analysis from various contract manufacturing organizationsí˜ Maintain a full understanding of all company SOPs and policies, along with all cGMP, CFR, and ICH guidance that are applicable to the manufacturing of finished drug productsí˜ Competitive Salaryí˜ Relocation assistance availableí˜ Annual bonus availability (based on yearly company and personal performance)í˜ Medical, dental and vision coverageí˜ Paid time off planí˜ 401k savings plan ( (*** No employer contribution)If you believe you would be a good fit for this position, please apply now.

Created: 2025-02-20