Director, Product Quality - CAR-T Programs - (Remote)

Job Locations US-CA-Thousand Oaks | US-Remote
ID
2021-1735
Category
Quality
Type
Regular Full-Time

Job Description

The Director, Product Quality (CAR-T programs) ensures a consistent quality oversight / approach throughout the Development Process and the Commercial Product Lifecycle across all Atara Allogenic CAR-T products. The Product Quality Leader manages a team who 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 Program Teams, 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%


Primary Responsibilities:

  • Directs team of PQLs who 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 quality.
  • 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 QbD principles across programs.
  • 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 partners and internal CMC teams, provides both strategic and tactical Quality decisions regarding innovative technologies, industry best practices, new regulations, and processes in end-to-end supply chain operations to enable the Atara allogeneic CAR-T platform.
  • Ensures strategic management of Quality Risk Management (QRM) for Atara early stage products.
  • Participates in and supports complex deviation investigations, Material Review Boards, Change Management, Specification Committee, critical quality complaint resolution activities. 
  • Develops guidance and supports the generation 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 CAR-T product teams are fully aligned around the Quality Strategy.
  • Partners with Regulatory Affairs to author, review, and approve filings, and represents Quality in product related agency meetings.
  • Represents product quality in meetings with regulatory agencies and supports regulatory inspections.

Qualifications

  • 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, experience in cell or gene therapy or biologics product development and licensure required.
  • Experience in early-stage cell therapies required, CAR-T experience preferred.
  • Knowledge of cell culture and virus manufacturing processes and methods.
  • Demonstrated ability to think strategically and to influence others.
  • Possess excellent verbal and written communication skills, good interpersonal skills.
  • 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 cycle management.
  • Demonstrated ability to collaborate cross-functionally, develop strong relationships with partners both internally and externally.
  • Exhibits highest integrity and committed to ethics and compliance standards.
  • Strong ability to prioritize and operate with a sense of urgency.
  • Flexibility to travel as required to accommodate the business needs.
  • 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 excellence.”

 

Our vision - “T-Cell Immunotherapy for every patient, any time.”

 

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.
 
 

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