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Senior Director, Clinical Quality Assurance

Company: Allogene Therapeutics, Inc.
Location: South San Francisco
Posted on: June 7, 2021

Job Description:

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

We are seeking a highly motivated individual for the role of Senior Director, Clinical Quality Assurance (CQA) at Allogene Therapeutics. This is a hands-on role where you will provide quality oversight to all clinical operations and clinical trials sponsored by Allogene Therapeutics. You will be primarily responsible for developing and spearheading Quality processes and procedures supporting Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP) activities.

Responsibilities include but are not limited to:

  • Develop and implement GCP quality oversight systems through development of standard operating procedures and work instructions that follow relevant guidance documents
  • Create and execute full clinical site qualification program through development of GCP auditing system and partnership with Clinical Operations team.
  • Perform CRO supplier risk assessments and establish and execute GCP, GVP, and GLP audit plans and compliance audits.
  • Collaborate with the Clinical Operations team, CROs and sites to effectively and efficiently set up the overall GCP and GVP oversight programs
  • Other duties as assigned

Requirements:

  • Bachelor's Degree in a scientific or related discipline with advanced degree preferred
  • 10+ years of experience in a GCP quality role, with at least 3 years leading the GCP function
  • Comprehensive knowledge of GCP, GVP, and GLP regulations and the ability to correctly interpret minimum standards
  • Proficient in MS Word, Excel, Power Point and other applications
  • Comfortable in a fast-paced start-up environment with minimal direction and able to adjust workload based upon changing priorities
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
  • Ability to work independently and as part of a team.
  • Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
  • Candidates must be authorized to work in the U.S.

As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

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Keywords: Allogene Therapeutics, Inc., South San Francisco , Senior Director, Clinical Quality Assurance, Other , South San Francisco, California

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