Director, Product Quality

Job Locations US-CA-Thousand Oaks
ID
2020-1303
Category
Quality
Type
Regular Full-Time

Job Description

The individual will provide technical expertise and leadership to Product CMC/Quality Teams to develop, implement, and manage the strategies for Quality to meet product goals. As a product expert in Quality, the Product Quality Director has responsibility for overseeing a group of cross-functional personnel to ensure all aspects of phase appropriate activities are managed.  Product Quality Director will work with management regarding operational/organizational strategy and have responsibility for providing technical input for late-stage and commercial regulatory files, comparability studies, RTQs, specifications and PQ operational strategies. 

As a product expert in Quality, the Product Quality Director has responsibility for working directly with CMC Leaders, Quality Control (QC), Regulatory, Process Sciences (PS), Quality Assurance (QA), etc. on the resolution of issues associated with process/manufacturing, In-Process Control (IPC), analytical methods, specifications, reference standards, importation testing, investigations, change control, regulatory submissions, international expansion and inspections related to product(s).

 

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.
  • 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 meetings.
  • Represents product quality in meetings with regulatory agencies and supports regulatory inspections.

 Travel: Up to 30%

 

 

Qualifications

Education and Professional Experience:

  • Requires a Bachelor’s Degree in Virology, Biochemistry, Microbiology, Molecular and Cellular Biology, or Biology
  • Minimum 15 years pharmaceutical experience, preferred experience in cell therapy or biologics product development and licensure.

Position Requirements:

  • Demonstrated expert knowledge of relevant global regulations and guidance required
  • Experience in cell line development, production and qualification of attenuated viral banks strongly preferred
  • Knowledge of product licensure submissions and processes required, ATMP submission preferred
  • Ability to think strategically and to influence others
  • Must 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
  • 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’re named after Atara Ciechanover who suffered from cancer before passing away. 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 350+ Atarians co-located by design in South San Francisco (corporate headquarters) and Southern California (R&D and manufacturing headquarters in the northwest Los Angeles area) with a newly-established European headquarters in Zug, Switzerland. Atara also has a R&D site in the Denver, Colorado area and an office in New York City. 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 in Thousand Oaks, California.

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.”

 

Visit www.atarabio.com 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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