Sr Manager Quality Assurance - Product Complaints
Company: Atara Biotherapeutics
Location: Thousand Oaks
Posted on: May 3, 2021
As a Sr. Manager, you will be a part of the Quality Assurance
team based in the Atara Technical Operations and Manufacturing
(ATOM) plant in Thousand Oaks, California. As the Business Process
Owner, you will manage Governance of the Product Complaint Process
which includes but not limited to resolving reported problems by
clarifying the complaint, determining the cause of the problem,
selecting, and explaining the best solution to solve the problem,
expediting correction or adjustment, and following up to ensure
You will have the overall responsibility to develop, implement
and sustain Complaints and associated Adverse Events, Product
Recalls, Biological Product Deviation Reporting (BPDR), and to
ensure the internal and external processes meet government and
health authority requirements. This role will require strategic
capabilities for program development and ownership including,
leading governance activities, and quality performance monitoring
and/or trending efforts and participating in risk management
processes. In addition to serving as a subject matter expert (SME)
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 complaint management system to scale and align with the
Work Location Thousand Oaks, CA
Reports to Sr. Director, External Quality
Travel Travel required (up to 10%).
- Act as an SME of global 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.
- Develop and maintain phase-appropriate Quality and Compliance
processes for product complaint systems occurring during the entire
lifecycle of the products including non-clinical development
through clinical investigational studies, commercial launch, and
post market surveillance.
- Respond to common inquiries or potential product complaints
from customers (including clinical study sites), regulatory
agencies, or internal/external team members.
- Manage the investigation process for product complaints from
initiation to effectiveness review and ensure the
investigation/CAPA process is compliant and effective.
- Develop, analyze trends, maintain, and report quality metrics
as appropriate for continual improvement programs and developing
QMS resource needs as the business grows.
- Partner with relevant SMEs to drive product complaint
investigations and the production of subsequent investigation
reports that meet regulatory timelines.
- Ensure coordinated deployment of new processes or enhancements,
within the ATOM site and across contract manufacturing
organizations (CMOs), as applicable.
- Partner with Information Technologies (IT) to define the
requirements for Quality electronic systems/databases as the
Business Owner, and co-lead implementation of these
- Support and lead internal and external audits/inspections and
contribute to the development of responses to
observations/questions from these audits and/or regulatory
- Drive quality responsibilities cross-functionally by developing
and deploying training for the process and system required for
investigational and commercial product complaints.
- Coach/mentor cross-functional colleagues to drive a
high-performance organizational culture.
- Responsible to influence and facilitate execution of key
projects and initiatives aligned with Technical Operations
- Bachelor's degree in a technical or science discipline (e.g.,
biology, biochemistry, chemistry, engineering).
- 8 years of experience in the biotechnology and/or
- Demonstrated knowledge of Quality Management System tools,
continuous improvement methodologies and in-depth understanding of
site level products and their related processes.
- Experience in participating in government and health authority
inspections, performing internal/external audits, and mock
- Functional working knowledge with global cGMPs and Quality
Management Systems, and auditing methods.
- Able to lead, develop, communicate, and implement a risk
management strategy under crisis situations to ensure data
integrity and compliance to relevant company procedures and
government and health authority regulations and guidelines.
- Demonstrated ability in understanding and maintaining global
GCP, GMP, and pharmacovigilance (PV) requirements for pharma and/or
- Strong technical aptitude.
- Hands-on experience with Quality systems, processes,
activities, and auditing methods
- Expertise in Root Cause Analysis methodologies
- Proven track record of planning and leading quality and
regulatory compliance programs and projects.
- Strong organizational skills and the ability to multitask; can
set priorities and follow established timelines.
- Must be a self-starter, collaborates cross-functionally, and
can work independently with minimal functional oversight.
- Ability to effectively operate across different stakeholder
management and influencing skills.
- Experience presenting to multiple levels of an
- 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 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
Our vision - "T-Cell Immunotherapy for every patient, any
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.
Keywords: Atara Biotherapeutics, Thousand Oaks , Sr Manager Quality Assurance - Product Complaints, Other , Thousand Oaks, California
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