Sr. Specialist QA – Audit Program and Compliance

Job Locations US-CA-Thousand Oaks
ID
2021-1717
Category
Quality
Type
Regular Full-Time

Job Description

As a Sr. Specialist QA, you will be a part of the Quality Systems & Compliance team based in Thousand Oaks, California.  As the Business Process Owner, you will have the overall responsibility to develop, implement and sustain the Atara Quality Audit Program ensuring compliance with internal requirements and external GMP regulations.  Responsible for a high level of understanding of the standards and principles of auditing and the auditing techniques of examining, questioning, evaluating, and reporting to determine a quality system's adequacy and deficiencies. Partner with business functions to ensure the successful implementation of the Audit Program. This role will require the strategic capability in the form of program development and ownership (including policies, procedures, leading governance, and quality performance monitoring efforts, etc.). In addition to serving as a subject matter expert in these areas, you will be responsible for maintaining strong, collaborative partnerships with cross-functional and cross-site team members and to create a successful program which would include but not be limited to, Internal, External (Partner), Supplier, Regulatory Body, and Clinical Audits.

 

Work Location             Thousand Oaks, CA

Reports to                   Director, Quality Systems & Compliance

Travel                          Travel required (up to 10%)


Primary Responsibilities

  • Responsible for implementation and maintenance of the Atara audit program
  • Responsible for the overall audit processes and assuring consistency across the audit program.
  • Develop and maintain phase-appropriate Quality processes, with respect to product lifecycle stages from non-clinical development through the life of the program, including commercial launch, and post market approval.
  • Ensure Internal Quality Audits, Supplier/Service Provider Audits, Contract Manufacturing Organizations and Contract Test Laboratory Audits are established, scheduled, and adhered to.
  • Responsible to be the in-room audit manager for all regulatory and external audits.
  • Lead, develop and implement regulatory inspection readiness activities.
  • Ensure inspection readiness of all internal and external entities in preparation of competent authority inspections.
  • Collaborate with all Atara Quality Operations team to assure all applicable groups are inspection ready and operate in a complaint manner with applicable regulatory guidance.
  • Responsible for the development and training of a cross functional audit cadre to execute and complete appropriate audit activities.
  • Perform periodic reviews of Audit Program documents to ensure the files remain reflective of data/trending signals and ongoing activities.
  • Support routine Quality processes such as investigating non-conformances, CAPAs, complaints, other process monitoring activities.
  • Assists in risk assessment process and preparation of audit plan that focuses on high-risk areas.
  • Establish and maintain strong and efficient communication lines to ensure audit findings are communicated, timely execution of corrective action and implementation of efficiency gains and process improvements.
  • Partner with Information Technologies (IT) to define the requirements for Quality electronic systems/databases as the Business Owner, and co-lead implementation of these requirements.
  • Act as subject matter expert (SME) of Audit Program, with responsibilities that include defining Key Performance Indicators (KPIs), monitoring system performance, and ensuring compliance to requirements and reporting during QMR. 
  • Measures and tracks the results of audits performed through action plan follow-up procedures.
  • Manage the development of responses to observations for external inspections and audits.
  • Provide recommendations for continuous improvement to strengthen the internal processes and structure.
  • Can function as a lead auditor for internal audits and perform audits to ensure compliance to internal and external requirements.

Qualifications

  • Bachelor’s degree in a technical discipline (e.g., biochemistry, chemistry, engineering).
  • 10+ years of experience in the biotechnology and/or pharmaceutical industry, (preferably both).
  • Demonstrated knowledge of Quality Audit Management, continuous improvement methodologies & in-depth understanding of site level products & related processes.
  • Experience in participating in regulatory inspections and managing Inspection process.
  • ASQ Quality Auditor Certification.
  • Experience with audit management databases/systems.
  • Strong working knowledge of regulatory requirements for major government bodies, including FDA (US), EMA (Europe) as well as WHO (World Health Organization)
  • Technical experience from working at a manufacturing facility with the ability to understand and interpret regulatory requirements.
  • Experience in compliance with quality standards in a Pharma/Biotech industry.
  • Ability to utilize Risk Based approaches to prioritize and take appropriate actions.
  • Ability to work effectively in a team environment and build strong working relationships.
  • Experience in project and/or program management leading cross-functional teams
  • Solid analytical skills with the ability to look at the big picture impact.
  • Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance.
  • Strong organizational skills and the ability to multitask; can set priorities and follow a timeline.
  • Self-starter, collaborates cross-functionally, and can work independently with minimal functional oversight.
  • Ability to effectively operate across diverse cultures with strong stakeholder management and influencing skills.
  • 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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