Director, Product Quality - CAR-T Programs - (Remote)
Company: Atara Biotherapeutics
Location: Thousand Oaks
Posted on: May 3, 2021
The Director, Product Quality (CAR-T programs) ensures a
consistent quality oversight / approach throughout the Development
Process and the Commercial Product Lifecycle for assigned Atara
CAR-T products. The Product Quality Leader acquires and applies
product-quality knowledge and acts as the quality expert for
assigned products throughout the product lifecycle working closely
with the product teams and partners.
Represents Quality in CMC Team, Program Team, and business
partner meetings to provide strategic direction and leadership to
product development, registration, and approvals.
Reports to: Sr. Director Product Quality Leadership
Location: Remote OR Thousand Oaks, CA
Travel: Up to 20%
- Serves as the quality expert for assigned ATARA CAR-T programs
and is responsible for making strategic quality decisions
throughout the product lifecycle. Provides a proactive front-end
approach to product quality.
- Provides direction and alignment across different functions and
influences both strategic and tactical Quality input to develop
product quality strategies and life cycle management decisions for
both clinical and commercial products in alignment with overall
product strategies and is accountable for decisions on product
- Actively monitors product metrics and signals (e.g. cpk
/stability, etc.) and initiates / supports improvement projects to
enhance performance and /or mitigate quality or compliance risks
across development portfolio.
- Works in partnership with Process Science to ensure there are
established overall Product Quality Profiles and implementation of
- Leads investigations in response to quality signals / complaint
trends or critical deviations. Actively gathers necessary SME's
(e.g. Technical/Regulatory) and leads team to resolve.
- In collaboration with operations, provides both strategic and
tactical Quality decisions regarding innovative technologies,
industry best practices, new regulations, and processes in
end-to-end supply chain operations.
- Supports and enables strategic management of Quality Risk
Management (QRM) for assigned Atara products.
- Participates in and supports complex deviation investigations,
Material Review Boards, Change Management, Specification Committee,
critical quality complaint resolution activities.
- Quality approver of key strategic product documents (e.g.
Specifications, Stability Plans, Process descriptions, QbD
documents, Process Development plans).
- Ensures holistic quality reviews are performed and standards
established for regulatory filings, inspections and compliance
audits as required.
- Acts as the lead Quality input to ensure the product teams are
fully aligned around the Quality Strategy.
- Owns the APR / PQR, coordinating cross functionally to ensure
regulatory requirements are met and that actions arising are
managed to conclusion.
- Interfaces with Regulatory Affairs to author, review, and
approve filings, and represents Quality in product related agency
- Represents product quality in meetings with regulatory agencies
and supports regulatory inspections.
- Demonstrated expert knowledge of relevant cell and gene therapy
global regulations and guidance required.
- Bachelor's Degree in Virology, Biochemistry, Microbiology,
Molecular and Cellular Biology, or Biology
- 15 years pharmaceutical experience, preferred experience in
cell or gene therapy or biologics product development and
- Experience in cell and gene therapies.
- Knowledge of cell culture and virus manufacturing processes and
- Ability to think strategically and to influence others.
- Possess excellent verbal and written communication skills; good
- Strong scientific and global cGMP compliance expertise to
ensure robust analysis of complex data to recommend and/or make
risk-based Quality decisions in biopharmaceutical product life
- Demonstrated ability to collaborate cross-functionally, develop
strong relationships with partners both internally and
- Exhibits highest integrity and committed to ethics and
- Strong ability to prioritize and operate with a sense of
- Flexibility to travel as required to accommodate the business
- Role model for Atara TRAIT values (Transparency, Respect,
Accountability, Integrity, Trust)
More about Atara Bio
We launched Atara Biotherapeutics in August 2012 to help
patients with serious diseases and few therapeutic options. We are
considered a leading off-the-shelf T-cell immunotherapy company
(Nasdaq ATRA) developing novel treatments for patients with cancer,
autoimmune and viral diseases.
We're proud of our team of 425+ Atarians co-located by design in
4 different locations including South San Francisco (corporate
headquarters), Thousand Oaks (R&D and manufacturing
headquarters), Zug, Switzerland (european headquarters) and a
R&D site in the Denver, Colorado area. Our Southern California
hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara
T-Cell Operations and Manufacturing (ATOM) facility. Our mission -
"Transform the lives of patients with serious medical conditions
through pioneering science, teamwork, and a commitment to
Our vision - "T-Cell Immunotherapy for every patient, any
Atara offers a competitive benefits packages that includes
medical/dental/vision benefits, life and disability, retirement and
stock program, as well as a generous paid time off and wellness
plan that supports the well-being of our staff. Visit
www.atarabio.com/careers to learn more.
Atara Bio is an equal opportunity employer and makes employment
decisions on the basis of merit and other lawful factors. In
accordance with applicable law, the Company prohibits
discrimination based on race, color, religion, creed, sex, gender
(including pregnancy, childbirth or medical condition related to
pregnancy or childbirth), gender identity, expression or dysphoria,
marital status, age, national origin or ancestry, physical or
mental disability, medical condition, genetic information, veteran
status, caregiver status, sexual orientation, transgender status or
any other classification protected by federal, state or local laws
or because of the individual's association with a member of a
protected group or connection to an organization or group related
to a protected group.We comply with all applicable national, state
and local laws governing nondiscrimination in employment as well as
employment eligibility verification requirements of the Immigration
and Nationality Act. All applicants must have authorization to work
for Atara Bio in the United States.
Keywords: Atara Biotherapeutics, Thousand Oaks , Director, Product Quality - CAR-T Programs - (Remote), Other , Thousand Oaks, California
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