Atara Biotherapeutics, Inc. Sr. QA Specialist in Thousand Oaks, California
As a Sr. Specialist, you will be a part of the Quality Systems & Compliance team based in the Atara Technical Operations and Manufacturing (ATOM) plant in Thousand Oaks, California. As the Business Process Owner, you will have the overall responsibility to develop, implement and sustain Deviation and CAPA Quality Systems, ensuring compliance with internal requirements and external GMP regulations. Responsible for 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 facilitate and manage a strategy that allows the system to scale and align with the business drivers.
Work Location Thousand Oaks (northwest Los Angeles area), CA
Reports to Director, Quality Systems & Compliance
Travel Travel required (up to 10%)
Act as subject matter expert (SME) of Quality Systems, with responsibilities that include defining Key Performance Indicators (KPIs), developing and maintaining company policies, standard operating procedures and work instructions incorporating best practices, implementation and effectiveness of Quality Management System per QMS and regulatory requirements, as appropriate.
Develop and maintain phase-appropriate Quality processes for Deviations and CAPA systems, with respect to product lifecycle stages from non-clinical development through the life of the program, including commercial launch, and post market approval.
Ensure coordinated deployment of new processes or enhancements, within the ATOM site and across contract manufacturing organizations (CMOs).
Partner with Information Technologies (IT) to define requirements for Quality electronic systems/databases as the Business Owner, and co-lead implementation of these requirements
Direct quality initiatives that accomplish continuous improvement and enhance process efficiencies, with connectivity to the Atara Integrated Management System (IMS)
Develop breadth of knowledge to accurately represent key requirements of systems managed by Quality Systems & Compliance teammates
Support and participate in internal audits and external inspections, and contribute to the development of responses to observations/questions
Drive quality responsibilities cross-functionally by developing and deploying training for the process and system.
Coach/mentor cross-functional colleagues to drive a high-performance organizational culture that accommodates rapid growth and highly dynamic expectations
Prepare oral and written communications to management with clarity and accuracy, using pre-defined standardized tools
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 Management System tools like Veeva, continuous improvement methodologies & in-depth understanding of site level products & related processes.
Experience in participating in regulatory inspections and performing internal audits.
Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance.
Strong analytical problem solving: Able to identify problems; apply structured and disciplined methodology to identify root cause.
Strong technical aptitude.
Strong operations support background ensuring value added and effective quality oversight.
Demonstrated ability to provide effective program leadership in terms of working with senior leadership to develop a network strategy and roadmap.
Proven track record of planning and leading programs and projects.
Strong organizational skills and the ability to multitask; can set priorities and follow a timeline.
Must be a self-starter, collaborates cross-functionally, and can work independently with minimal functional oversight.
Ability to effectively operate across different cultures with strong stakeholder management and influencing skills.
Extremely proficient written and verbal communication skills with experience presenting to multiple levels of an organization.
Role model for Atara TRAIT values (Transparency, Respect, Accountability, Integrity, Trust)
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 400+ 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.”
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.
Official Title: Sr. QA Specialist
Job ID: 2021-1498
External Company Name: Atara Biotherapeutics, Inc.
External Company URL: https://www.atarabio.com/