Associate Director, QA GMP Compliance in San Diego, CA

$80K - $100K(Ladders Estimates)

Arena Pharmaceuticals, Inc   •  

San Diego, CA 92101

Industry: Pharmaceuticals & Biotech


8 - 10 years

Posted 37 days ago

This is an exciting time to join Arena Pharmaceuticals, a clinical stage biotechnology pharmaceutical company with a robust portfolio of assets across multiple therapeutic areas.

We are seeking an Associate Director, QA GMP compliance reporting to the Director of Quality Assurance. This individual will manage activities relating to Quality Assurance systems supporting Phase I-III clinical development. The candidate will be interacting with cross-functional groups such as Tech Ops, Regulatory Affairs, Clinical, and Contract Manufacturing Organizations and Contract Laboratories.

What you'll dive into:

  • Perform lot release for multiple CMO batches
  • Maintain lot release database and compile reports
  • Review and approve deviations, OOS, and other compliance issues
  • Approve analytical protocols and reports, material specifications, expiry date extensions, and cleaning validations
  • Review and approve label proofs
  • Audit contract manufacturing organizations
  • Conduct internal audits
  • Conduct final lot release on manufactured drug substance, drug product and clinical trial materials
  • Follow up in a timely fashion on potential issues impacting lot release, to ensure lot release occurs per the timeline. Request missing documents directly from the Contract Manufacturing Organization (CMO)
  • Communicate clearly to management the lot release status for all Contract Manufacturing Organizations
  • Review and approve deviations, investigations and corrective actions to ensure compliance and completion within the required deadline. Enter those items into the CMO Compliance Log
  • Review and approve Method Validations, Method Transfers, Material Specifications, Stability Data, Expiry Date Extensions, and Cleaning Validations
  • Approve GMP shipments to various CMOs or Contract Labs
  • Review and Approve Label Proofs by the required deadline and communicate errors found to clinical supply team
  • Revise and Implement Standard Operation Procedures
  • Perform external audits, as needed
  • Perform internal audits, as needed
  • Other duties as assigned

What we expect:

  • BA/BS in Biology or related Science preferred, or equivalent experience
  • 8-10 years experience in Pharmaceutical and/or Biotech related fields, knowledge of cGMP; Candidate must have strong background in Drug Substance and/or Drug Product Manufacturing
  • Strong organizational, interpersonal and communication skills, and excellent written communication with the ability to write SOP's concisely and accurately
  • Must be able to communicate efficiently with Contract Manufacturing Organizations and with internal cross-functional teams
  • Must be knowledgeable in using multiple computer programs (MS Office Suite, Sharepoint, Smartsheet and Adobe Acrobat)
  • Global travel up to 25% of time may be necessary

What you'll get:

  • To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people's lives
  • Opportunities to learn and contribute creative solutions
  • Comprehensive health insurance ($0 premium on select medical plans)
  • Matching 401k retirement plan
  • Paid time off and holidays
  • Company celebrations

Valid Through: 2019-10-7