Sr. Specialist QA - Audit Program and Compliance
Company: Atara Biotherapeutics
Location: Thousand Oaks
Posted on: June 13, 2021
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
Work Location Thousand Oaks, CA
Reports to Director, Quality Systems & Compliance
Travel Travel required (up to 10%)
- Responsible for implementation and maintenance of the Atara
- 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
- 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
- Perform periodic reviews of Audit Program documents to ensure
the files remain reflective of data/trending signals and ongoing
- Support routine Quality processes such as investigating
non-conformances, CAPAs, complaints, other process monitoring
- 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
- Partner with Information Technologies (IT) to define the
requirements for Quality electronic systems/databases as the
Business Owner, and co-lead implementation of these
- 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
- 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
- Experience in compliance with quality standards in a
- Ability to utilize Risk Based approaches to prioritize and take
- Ability to work effectively in a team environment and build
strong working relationships.
- Experience in project and/or program management leading
- Solid analytical skills with the ability to look at the big
- Demonstrated ability to lead, acknowledge, develop, communicate
& implement a strategy under crisis situations to ensure
- 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
Our vision - "T-Cell Immunotherapy for every patient, any
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. Specialist QA - Audit Program and Compliance, Other , Thousand Oaks, California
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