Quality Assurance Manager - Abzena

Quality Assurance Manager

Location: San Diego, CA
Area: Quality

The Quality Assurance Manager will provide quality oversight for development, cGMP manufacturing and GMP testing of Drug Substance, Intermediate Materials, and Cell Banks intended for clinical use.  The Quality Assurance Manager will be responsible for applying GMP controls and monitoring quality expectations for product development in a phase appropriate manner.  This position is a supervisory role.  Primary responsibilities include review of GMP records for product release and support of quality systems activities related to training, internal/external audits, investigations, CAPA, and change management.  This is a supervisory position which reports to the Senior Vice President of Global Quality.

 

Main Responsibilities

  • Oversee compliance manufacturing and testing activities with respect to procedures as well as FDA, EU, ICH, and other regulatory expectations and requirements
  • Provide regulatory support to manufacturing department to make sure phase appropriate requirements for product development are met
  • Provide quality input for failure analysis, problem solving, and risk assessment and mitigation activities related to the qualification and validation of the GMP facility and equipment
  • Review and provide inputs for CMC sections of client’s IND and IMPD submissions for Drug Substance, Drug Products and stability studies
  • Work closely with project managers to coordinate GMP related activities to make sure that client’s time lines are met
  • Works closely with manufacturing team to ensure proper preparation and submission of comprehensive manufacturing documentation
  • Facilitate interactions between Quality, GMP Production and QC testing groups to help set and meet timelines while maintaining compliance
  • Review and approve client specific production batch records and analytical method validation protocols
  • Review executed manufacturing batch records and analytical method validation reports for compliance; assure Drug Substance and Drug Products lots were processed per current manufacturing instructions and conform to quality standards and governmental regulations
  • Lead and manage GMP investigations of product specific deviations, OOS, OOT and corrective actions to ensure compliance and completion within a specified time frame
  • Perform problem solving for issues pertaining to GMP production
  • Disposition GMP production batches to support clinical use
  • Generate meaningful quality metrics to determine process performance
  • Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results with a customer driven focus

 

Qualifications/Skills Required Essential:

  • Bachelor’s degree in a relevant discipline (e.g., chemistry, biological sciences, bioengineering, etc.)
  • Broad knowledge of drug development
  • Minimum 10 years of experience in the pharmaceutical industry
  • At least six (6) years of Quality -related experience in a current Good Manufacturing Practices (cGMP) environment
  • Knowledge of and proficient in FDA, EU, and ICH regulatory requirements and guidelines related to cGMP operations
  • Practical knowledge of aseptic processing with respect to drug product formulation
  • Ability to manage manufacturing investigations
  • Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity
  • Ability to effectively interact and communicate with customers in a professional manner

 

Desirable:

  • Demonstrate sense of urgency; ability to recognize time sensitivity
  • Flexible and adaptable style with an eagerness to take on challenges
  • Problem solver who not only identifies issues but leads efforts to resolve them
  • Experience of working within both biologics and small molecule manufacturing Quality environments
  • Strong leadership and motivational capabilities
  • Ability to supervise and manage employees
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