Overview
Quality Assurance Officer/AD or Higher Jobs in Sacramento, California, USA at EPM Scientific – Phaidon International
Position: 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 their Quality department as they are building a manufacturing site at their Sacramento branch.
Key **
Enforce GMP compliance.
Provide Quality and Compliance oversight of drug supply operations.
Work closely with the regulatory affairs department to ensure quality and compliance issues related to customer complaints, adverse events, quality events, market recalls, and pharmacovigilance reporting.
Prepare for FDA audits.
Lead FDA audits.
Perform 3rd party vendor audits, including contract manufacturing organizations, 3rd party logistics, contract research organizations, contract research laboratories, API manufacturers, raw material suppliers, and primary/secondary packaging material suppliers.
Lead audits and interface with customers and regulatory representatives.
Perform vendor qualification for the API, raw material, and primary/secondary finished goods.
Draft, review, and approve quality agreements between the company and contracted organizations, including but not limited to contract manufacturers and contract labs.
Review finished product certificates of analysis from various contract manufacturing organizations.
Maintain a full understanding of all company SOPs and policies, along with all cGMP, CFR, and ICH guidance applicable to the manufacturing of finished drug products.
Competitive Salary.
Relocation assistance available.
Annual bonus availability (based on yearly company and personal performance).
Medical, dental, and vision coverage.
Paid time off plan.
401k savings plan (
*** No employer contribution).
If you believe you would be a good fit for this position, please apply now.
J-18808-Ljbffr
Title: Quality Assurance Officer/AD or Higher
Company: EPM Scientific – Phaidon International
Location: Sacramento, California, USA
Category: Quality Assurance – QA/QC, Manufacturing / Production
