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Associate Director, Quality Assurance

Company: Allogene Therapeutics
Location: Newark
Posted on: August 2, 2022

Job Description:

Associate Director, Quality Assurance Location: Newark, CA Position type: FULL-TIMEAbout Allogene Therapeutics, Inc: Allogene Therapeutics is a clinical-stage biotechnology company with a single-minded focus on pioneering the development of investigational allogeneic chimeric antigen receptor T cell (AlloCAR T---) products for cancer. Led by world-class management with significant experience in cell therapy, our fully integrated, in-house team of researchers is dedicated to discovery and translational research, development, and cell manufacturing.At Allogene, we are developing a pipeline of off-the-shelf CAR T cell candidates, with the goal of delivering readily available cell therapy faster, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.About the role: Allogene is seeking an Associate Director to support the Newark multiproduct manufacturing facility to oversee the quality of the site's production by working collaboratively with manufacturing operations, facility/engineering, environmental monitoring/microbiology, and supply chain. The position will be responsible for supporting quality management system and providing direction and decision-making regarding quality operations. Must be able to work independently and professionally in the execution of production. Must be able to manage responsibilities in a fast-paced environment, meeting production objectives, while ensuring quality requirements are met. Excellent communication skills and demonstrated ability to work well with others will be essential.Responsibilities include, but are not limited to:

  • Provides Quality functional leadership including hiring and managing, high performing quality assurance staff designed to meet the technical and compliance requirements of a growing company.
  • Provides Quality leadership to meet the technical and compliance requirements for facility design and qualification
  • Work with Newark Team to support facility start-up, validation, and qualification activities- reviewing and approving documents
  • Provide QA on-the-floor support and training on Quality Assurance topics
  • Write Quality procedures, policies, risk assessments, and training materials
  • Provide oversight of tech transfer activities which many include review and approve utility/facility/ equipment qualification, change control, batch records and technical reports.
  • Collaborate and support analytical transfers, qualification and validation as needed
  • Provides guidance with respect to regulations, guidelines, and emerging inspectional trends in developing Quality management systems and functionality
  • Pro-actively and independently identify and mitigate key cross-functional issues with limited need to escalate.
  • Support the preparation of relevant sections of regulatory submissions and response materials
  • Drives continuous improvement utilizing quality tools such as lean, six sigma, and risk management.
  • Deliver project status updates to senior/executive management as needed.
  • Other duties as assignedPosition Requirements & Experience:
    • At least 7 years in a technical role in quality assurance, manufacturing, QC or quality engineering with demonstrated manufacturing plant experience with at least 3 years in a related people management role.
    • Bachelor's degree in Engineering, Chemistry or biological sciences required. Advanced degree preferred (education or training in cell culture and gene therapy a plus), ASQ Auditor certification, ASQ Quality Engineer certification preferred.
    • Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
    • Ability to effectively work in a fast-paced, start-up environment, while dealing with ambiguity.
    • Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
    • 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 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. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients

Keywords: Allogene Therapeutics, Newark , Associate Director, Quality Assurance, Executive , Newark, California

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