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Specialist/Senior Specialist, Quality Assurance

Company: Audentes Therapeutics, Inc.
Location: South San Francisco
Posted on: June 8, 2021

Job Description:

Why Work for Us

Are you ready to use your experience and expertise to make an impact on patients' lives? Astellas Gene Therapies is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you'd like to be a part of this important mission, please apply to join our team.

About Astellas Gene Therapies

Astellas Gene Therapies is developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for the newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website:

Our Values:

  • Be BOLD (Find a Way)
  • Care Deeply - for our patients, each other and our work
  • #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

We are seeking a highly motivated Specialist/Senior Specialist, Quality Assurance (QA) who will provide input and oversight to ensure all operations meet or exceed cGMP regulations, ensuring a high level of quality and compliance of the Gene Therapy and Plasmid Manufacturing operations, Facilities/Engineering, Warehouse/Supply Chain and Quality Control (QC). The Specialist/Senior Specialist, QA will focus on partnering with stakeholders to review and approve deviations, out-of-specification (OOS) investigations, work orders, standard operating procedures (SOPs), and lead root cause analysis discussions. The Specialist/Senior Specialist, QA will collaborate with Change Control Owners for change control evaluation and approval. This is accomplished by direct collaboration and oversight of QC Operations, Facilities/Engineering, Gene Therapy and Plasmid Manufacturing Operations and the review/audit of data and reports as specified by SOPs. This position will also support quality key metrics tracking, reporting and analysis. The Specialist/Senior Specialist, QA will be located in our South San Francisco offices and report to the Senior Manager, Quality Operations.

Primary Responsibilities

  • Perform Quality records review including data integrity oversight in a cGMP regulated biologics manufacturing environment, with a focus on novel challenges of cell based and gene therapies.
  • Ensure that Audentes' Quality requirements are being fulfilled through effective performance monitoring, quality agreement establishment and conducting assessments of current practices in preparation for commercialization.
  • Primary point of contact for support functions including Manufacturing and Development, QC, Facilities/Engineering and Supply Chain/Warehouse. Work closely with all GMP functional groups to support development and manufacture of gene therapy technologies for clinical and commercial use with applicable stakeholder functions.
  • Partner with Manufacturing in the review and Quality approval of characterization protocols and reports.
  • Assess and facilitate quality impact of deviations, OOS investigations, review and approve work orders and change controls
  • Facilitate risk assessments, cross functional team discussions in support of major/critical deviation investigations and change controls as they relate to QC, Facilities/Engineering and warehouse/Supply Chain
  • Draft risk assessment report documents as per defined timelines
  • Identify best practices and lead site teams to implement continuous improvement projects and drive for timely results with quality output
  • Able to identify and implement solutions for complex problems
  • Effectively drives for results and effectively network and communicate cross-functionally, cross-site
  • Makes informed timely decisions largely in an independent fashion; assumes responsibility and communicate to appropriate stakeholders
  • Assist in the preparation and hosting of regulatory (e.g. FDA, EMA, DHHS, etc.) regulatory inspections as necessary.

About you

Must Have/Required

  • Specialist: BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college with 8+ years relevant experience or Master's degree with 6+ years relevant experience
  • Senior Specialist: BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college with typically 10+ years relevant experience or typically 8+ years with Master's degree
  • Broad Quality Management System (QMS) experience supporting commercial operations of biologics manufacturing
  • Expertise in Quality decision making and regulatory compliance with respect to investigations and process change controls
  • Strong problem-solving, decision-making skills, interpersonal skills and ability to work in a team environment
  • Strong understanding of FDA, EMA, local regulations and guidelines, Good Engineering Practices, ICH guidelines, and industry best practices
  • Quality Assurance experience using risk based approaches, e.g., failure mode and effects analysis, hazard analysis and critical control points, etc.
  • Demonstrated experience with investigations into manufacturing deviations and determination of product impact potential, root cause, and corrective actions
  • Excellent technical writing, verbal communication and time management skills
  • Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done - is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

May Have/Preferred

  • Advanced degree in applicable field
  • Knowledge of existing and emerging regulations, standards, or guidance documents related to AAV gene therapy production
  • Experience with a global QMS system integration
  • Experience with board of health inspections and direct interaction with inspectors

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

Keywords: Audentes Therapeutics, Inc., South San Francisco , Specialist/Senior Specialist, Quality Assurance, Other , South San Francisco, California

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