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 Responsibilities:
Ø Enforce GMP compliance
Ø Provide Quality and Compliance oversight of drug supply operations
Ø Work closely with regulatory affairs department to ensure quality and compliance issues related to customer complaint, adverse events, quality events, market recalls, and pharmacovigilance reporting
Ø Prepare for FDA audits
Ø Lead FDA audits
Ø 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 supplier
Ø Lead audits and interface with customers and regulatory representatives
Ø Perform vendor qualification for the API, raw material and primary/secondary finished goods
Ø Draft, review and approve quality agreements between the company and contracted organizations including but not limited to contract manufacturer, contact lab etc.
Ø Review finished product certificate of analysis from various contract manufacturing organizations
Ø 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 products
Benefits:
Ø Competitive Salary
Ø Relocation assistance available
Ø Annual bonus availability (based on yearly company and personal performance)
Ø Medical, dental and vision coverage
Ø Paid time off plan
Ø 401k savings plan ( (Note: No employer contribution)
If you believe you would be a good fit for this position, please apply now.
