Senior Director, Commercial Product Quality
Company: Gilead Sciences, Inc.
Location: Santa Monica
Posted on: June 15, 2022
Job Description:
Senior Director, Commercial Product QualityJob
DescriptionEveryone at Kite is grounded by one common goal - curing
cancer. Every single day, we seek to establish a direct line
between that purpose and our day-to-day work. Join us in our
mission!SummaryWe are seeking a Senior Director, Commercial Product
Quality to lead the Product Quality organization for Kite's
commercial products. You will provide technical expertise and
leadership to Product CMC/Quality Teams to develop, implement, and
manage the strategies for Quality to meet late-stage clinical and
commercial product goals. As a product expert in Quality, this role
has the responsibility to lead the group of commercial Product
Quality Leads (PQLs) and the Stability Leads for technical
expertise and project support for the Quality and Compliance
aspects of the product throughout its life cycle. You and/or your
team members will be the Quality representative on the Operations
Team, developing and driving CMC strategies in the Technical
Operations organization, operationalizing the product strategy and
leading the alignment within the broader Quality organization and
with the sites. You will help to define the operational Quality and
Compliance strategy with the team who will be active in the
execution of the strategies supporting the commercial Operations
Team.As a product expert in Quality, the Commercial Product Quality
Lead role has responsibility for working directly with Operations
Leaders, Quality Control (QC), Regulatory Affairs, Process
Development (PD), Quality Assurance (QA), Qualified Persons, and
Manufacturing on the resolution of issues and implementation of
strategies associated with cell therapy products. This includes
topics related to technology transfers, manufacturing process
improvements, in-process control and critical quality attribute
trends, analytical methods (implementation of new methods,
transfers, validation, performance and improvements), establishment
of and revisions to final product and starting material
specifications, reference standards, importation testing,
investigations, change controls, regulatory submissions, annual
product reviews, continued process verification, risk assessments
and regulatory inspections related to product(s). Your work will
driveinitiatives intended to ensure the overall product
health.Duties & Responsibilities:
- Provide Quality leadership on cross-functional teams in a
matrix environment, driving alignment and decision making,
performing a scientifically sound and risk-based evaluation of
process and product quality data, and developing patient-oriented
strategies.
- Represent Quality on the Operations Team. Communicate the
product strategy and drive alignment within the broader Quality
organization and with the sites.
- Execute/drive product strategies through strong quality and
scientific leadership related to technology transfers, global
regulatory filing strategies, analytical method improvements,
stability, product specifications and program improvements.
- Support operationalizing theoretical concepts (e.g. product
strategies) into actionable plans and execute those plans with
successful outcomes.
- Negotiate plans with regulatory authorities and internal
multi-functional teams to obtain the optimal product quality
position for life cycle management
- Sponsor the global Commercial Product Quality Team, lead by the
PQLs.
- Develop strategies for regulatory submissions with the
Operations Team. Author sections of regulatory submissions and
communications, as needed. Review and approve CMC submissions and
regulatory communications to assure overall quality and scientific
soundness.
- Lead the development and revision of final product, product
intermediate and critical process material (e.g., viral vector)
specifications in conjunction with Process Development, Analytical
Development, QC, Translational Medicine and Clinical Development
teams. Drive decision making and alignment for final product and
viral vector specifications through the Specification Committee
(comprised of Technical Operations and Regulatory Upper
Management).
- Support development of the stability strategy of the
product
- Lead/Sponsor the annual product review or product quality
review (APR/PQR) process for commercially marketed products
- Support product quality data monitoring programs (i.e.,
continued process verification). Drive the connection with the APR
process.
- Accountable for policies and SOPs related to product and
process material specifications, stability and the APR
processes.
- Manage ownership or Quality approval of change controls,
deviations and CAPAs related to product and process material
specifications, stability and the Annual Product Reviews.Basic
Qualifications:--- Advanced degree and 12+ years' experience in
biotech / biopharma, technical operations OR--- Master's Degree and
12+ years' experience in biotech / biopharma, technical operations
OR--- Bachelor's Degree and 14+ years' experience in biotech /
biopharma, technical operations OR--- High School Degree and 18+
years' experience in biotech / biopharma, technical
operationsPreferred Qualifications / Skills:
- 10+ years working in a regulated environment (either direct GMP
or technical support)
- Excellent interpersonal, verbal and written communication
skills, including facilitation and presentation skills, are
essential in this collaborative work environment.
- Communicate complex ideas succinctly and clearly, both verbally
and in writing, to a variety of audiences.
- Ability to influence others through persuasive interactions and
garner support for novel solutions where applicable.
- Must be able to manage and prioritize workloads of staff
members, who themselves must be able to work on multiple projects
simultaneously and demonstrate ability to organize, prioritize and
manage time
- Comfortable in a fast-paced company environment with minimal
direction and able to adjust workload based upon changing
priorities.
- Experience with authoring or review of biological license
applications/MAAs, INDs/IMPDs, supplements/variations or similar
regulatory documentation, highly desired.
- Experience supporting non-conformance investigations,
authoring, reviewing and defending critical product impacting
non-conformances
- Ability to work and navigate within an evolving scientific and
regulatory environment.
- Familiarity with compliance and regulatory requirements of the
FDA as well as international regulatory agencies in international
expansion regions, preferred.
- Experience in direct interaction with regulatory
agencies/Boards of Health during inspections
- Understanding of biologic product development and manufacturing
principles.
- Knowledge of cGMP and filing regulations, guidelines,
practices, and trends pertaining to the manufacture and testing of
biopharmaceuticals is preferred.
- Previous experience working on a cross-functional team in a
matrix environment is a plus.Does this sound like you? If so, apply
today! Share: Job Requisition ID R0029118 Full Time/Part Time
Full-Time Job Level Director Click below to return to the Gilead
Careers siteClick below to see a list of upcoming eventsClick below
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Keywords: Gilead Sciences, Inc., Santa Monica , Senior Director, Commercial Product Quality, Executive , Santa Monica, California
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