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Associate Director, Product Quality Leader

Company: Audentes Therapeutics, Inc.
Location: San Francisco
Posted on: June 13, 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 and experienced Associate Director, Product Quality Leader (PQL) who will report to the head of QA Systems & Compliance. The PQL is a key role that will be responsible for quality assurance oversight of Astellas Gene Therapies' products from development through commercialization. The PQL is responsible for quality oversight of product lifecycle activities for Gene Therapy products. The role is the main point of contact for strategic Quality related topics on Non-Clinical Development/CMC teams. The PQL is also responsible for defining and oversight of the Quality risk management program for gene therapy products.

The successful PQL candidate possesses a broad range of knowledge and experience in biologic product development, commercialization, quality risk management, and has demonstrated expertise related to the international regulatory landscape. In depth knowledge and broad expertise with biologic/gene therapy products from a quality perspective are required. The candidate must possess technical expertise in these areas of responsibility and demonstrate collaborative leadership qualities.

The PQL influences across multiple disciplines to define a clear quality strategy to maintain and improve product quality. The PQL maintains close working relationships with leaders in Technical Operations, Quality Control, Process Development, Manufacturing, Regulatory Affairs and Quality Operations. The PQL has demonstrated expertise to influence quality strategy to ensure compliant development, successful licensure, and sustainable manufacturing of commercial gene therapy products. The PQL works closely across disciplines to define quality strategy and resolve and drive quality related aspects of development and manufacturing including technology transfer, product development, introduction of product and process changes, process and product monitoring, analytical method development, transfer and validation, development and qualification of reference standards, non-conformance investigations, change controls and CAPAs, regulatory submission drafting, Pre-approval inspection readiness and support, critical issue management, annual product reviews and risk management programs.

The PQL utilizes quality risk management principles to link critical parameters and quality attributes from product definition, through product development and commercialization. Risk management responsibility extends to development and oversight over the risk management program and includes product quality risk log development to ensure that risk related signals are documented, tracked, escalated and mitigated. This role will be located in our South San Francisco, CA location.

Primary Responsibilities

  • Develops and drives product quality strategies from non-clinical development through the life of the product including product definition, development, validation, submission, commercial launch and routine commercial manufacturing.
  • Supports product development from clinical to commercial, new product introductions and tech transfers across the gene therapy network.
  • Represents the Quality perspective in a matrix environment on non-clinical development, CMC and other teams, to help drive alignment and drive quality decision making.
  • Ensures reliable supply of quality product to support studies and patients throughout the lifecycle.
  • Interprets and applies applicable Health Authority regulations and guidance.
  • Provides technical expertise and Quality leadership throughout the product lifecycle.
  • Supports regulatory filings through drafting and review of regulatory submissions and supporting documentation.
  • Promotes clear and consistent approaches to help establish critical parameters, attributes and specifications.
  • Ensure alignment of product changes and collaborates with key leaders to develop strategies to ensure product supply and improve product and process robustness.
  • Establishes and refines quality risk management program.
  • Leads, facilitates, and authors product risk assessments to identify key product quality issues and risks, raise awareness of risks, document them on risk registers and escalates, as appropriate.
  • Defines and monitors product quality health metrics, including the Annual Product Review.

About you

Must Have/Required

  • Bachelor's degree in a scientific or technical discipline, and 10+ years of pharmaceutical experience in biotechnology or pharmaceutical industry in quality or quality systems in people or team leadership roles, 8+ years of experience with MS and 6+ years of experience with PhD, or equivalent combination of education and experience.
  • Experience in pharmaceutical product development, manufacturing, validation, quality control, quality assurance, quality compliance and/or quality engineering.
  • Experience planning for, participating in and responding to health authority inspections.
  • Demonstrated knowledge of cGMPs and health authority regulations as they relate to drug manufacturing operations.
  • Understanding of process validation concepts and regulations as it relates to product realization.
  • Knowledge of drug development processes and linkage to process validation and regulatory submissions.
  • Advanced project management skills and experience and demonstrated ability to drive quality initiatives.
  • Excellent written and oral communication skills and ability to translate complex concepts into simple solutions.
  • Ability to develop and maintain working relationships across multiple disciplines and levels in the organization.
  • Proven experience influencing others and leading in a matrix organization to drive quality and compliance.
  • Ability to build and implement risk management programs and drive risk-based decisions.
  • Experience with product monitoring and compliance related documentation, including annual product reviews.
  • Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects.
  • Limited travel, up to 10% may be required.
  • Strong analytical, communication, and negotiation skills as well as sound judgment, with the ability to work effectively with others.
  • Advanced computer skills with working knowledge of MS office such as Word, Excel, Access, Adobe Acrobat, Box, eQMS systems, EDMS and ERP systems.
  • 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

  • Experience in a both development and commercial quality operations and compliance experience.
  • Experience interacting with multiple international regulatory agencies, eg US, EU, Japan and ROW.
  • Experience in product quality and compliance of biologics, gene therapy related products and/or combination products.
  • Ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines.
  • Ability to deal with ambiguity, creative and pragmatic approach to problem solving.
  • Prior experience supporting regulatory authority inspections and inspection readiness activities.
  • Experience developing and monitoring quality metrics and broad experience across multiple quality disciplines, eg Quality Systems, Quality Compliance, Quality Operations, and Quality Engineering etc.

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., San Francisco , Associate Director, Product Quality Leader, Other , San Francisco, California

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