Director/Associate Director Quality Assurance GMP and GLP Compliance

San Diego, CA

Imbria Pharmaceuticals’ mission is to translate our understanding of cellular metabolism into innovative medicines that improve the lives of patients with limited or inadequate treatment options. The company was founded by doctors and launched by an all doctor executive team motivated by the promise of bringing new therapies to people in need.

We are propelled by a deep scientific interest in cellular metabolism and the mitochondria, and are guided by both values and a code of business conduct built upon our commitment to always put the patients, families and communities we serve at the forefront of all that we do. More information can be found at www.imbria.com.

The Director/Associate Director, QA GMP/GLP Compliance, is responsible for developing, establishing, implementing, and managing toward a highly effective Quality Assurance system. This position will report to the Head of Technical Operations and Manufacturing will manage activities related to Quality Assurance Systems. This individual will be interacting with cross-functional groups such as Tech Ops, Clinical Ops, Regulatory Affairs, Legal, and Contract Manufacturing Organizations and Contract Laboratories in supporting Imbria’s ongoing drug development programs.

Key Responsibilities:

  • Establish, maintain and grow Imbria quality assurance program
  • Create and implement a quality systems program
  • Draft and/or organize and Implement Standard Operating Procedures (SOPs)
  • Provide period GMP/GLP training
  • Ensure quality control of all products produced our suppliers
  • Work with CRO/CDMO teams to resolve quality issues
  • Perform batch record review for multiple CDMO batches on manufactured drug substance, drug product and clinical trial materials
  • Maintain lot release database and compile lot history files
  • Review and approve deviations, OOS, and other compliance issues. 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 CDMO.
  • Approve analytical protocols and reports, material specifications, expiry date extensions, and cleaning validations
  • Conduct internal and audits of CMOs
  • Communicate clearly to management the lot release status for all CDMOs
  • Review and approve Method Validations, Method Transfers, Material Specifications, Stability Data, Expiry Date Extensions, and Cleaning Validations
  • Approve GMP shipments to various CDMOs or Contract Labs
  • Review and approve Label Proofs by the required deadline and communicate errors found to clinical supply team

Minimum Education, Experience, Knowledge and Skills Required:

  • S/B.A. or M.S. in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, Chemistry or related scientific discipline
  • 5-10 years in Pharmaceutical and/or Biotech related fields with strong working knowledge of quality systems and regulations (GMP, GLP, and/or GCP).
  • Strong experiences in Drug Substance and/or Drug Product release and quality control
  • Strong organizational, interpersonal and communication skills, and excellent written communication with the ability to write SOP’s and audit reports concisely and accurately
  • Self-motivated and be able to communicate efficiently with CDMO/CRO and with internal cross-functional teams and prioritize multiple tasks
  • Strong collaboration, strategic thinking, leadership, and teamwork skills
  • Must be knowledgeable in using multiple computer programs (MS Office Suite, Sharepoint, Smartsheet and Adobe Acrobat)
  • Travel is required and estimated at about 15%

Imbria offers an attractive salary and benefits package, including equity incentives. To apply, please submit your resume to hr@imbria.com.