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Sr. Manager / Associate Director, Product Quality (REMOTE)

Company: Atara Biotherapeutics
Location: Thousand Oaks
Posted on: June 9, 2021

Job Description:

Job Description

This position supports a consistent quality oversight / approach throughout the Development Process and the Commercial Product Lifecycle for assigned Atara products. The Product Quality Leader acquires and applies product-quality knowledge and acts as the quality expert for assigned products or intermediates throughout the product lifecycle working closely with the product teams and partners.

Reports to: Director Product Quality Leadership

Location: Thousand Oaks, CA OR Remote

Travel: Up to 20%

Primary Responsibilities:

  • Serves as the quality expert for assigned ATARA 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.
  • 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 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.
  • Represents Quality in CMC Team, Program Team, and business partner meetings to provide strategic direction and leadership to product development, registration, and approvals.
  • Manages 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 meetings.

Qualifications

  • Bachelor's Degree in Virology, Biochemistry, Microbiology, Molecular and Cellular Biology, or Biology.
  • 10+ years pharmaceutical experience, preferred experience in cell therapy or biologics product development and licensure.
  • Demonstrated expert knowledge of relevant global regulations and guidance.
  • Experience supporting commercial GMP products including regulatory inspections.
  • Experience in cell-based process development and validation.
  • Experience in product licensure.
  • Knowledge of ATMP guidance.
  • Ability to think strategically and to influence others.
  • 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.
  • Collaborate cross-functionally, develop strong relationships with partners both internally and externally.
  • Confident, independent, self-starter, proactive, and results-oriented with high performance standards.
  • 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.

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.

Keywords: Atara Biotherapeutics, Thousand Oaks , Sr. Manager / Associate Director, Product Quality (REMOTE), Other , Thousand Oaks, California

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