Associate Director, Product Quality Leader
Company: Audentes Therapeutics, Inc.
Location: San Francisco
Posted on: June 13, 2021
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: www.audentestx.com.
- 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.
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
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
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.
- 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
- 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
- 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
- Defines and monitors product quality health metrics, including
the Annual Product Review.
- 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 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
- 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
- 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
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
Didn't find what you're looking for? Search again!