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Sr Manager Quality Assurance - Product Complaints

Company: Atara Biotherapeutics
Location: Thousand Oaks
Posted on: May 3, 2021

Job Description:

Job Description

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 resolution.

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 business drivers.

Work Location Thousand Oaks, CA

Reports to Sr. Director, External Quality

Travel Travel required (up to 10%).

Primary Responsibilities

  • 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 requirements.
  • Support and lead internal and external audits/inspections and contribute to the development of responses to observations/questions from these audits and/or regulatory inspections.
  • 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 vision.

Qualifications

  • Bachelor's degree in a technical or science discipline (e.g., biology, biochemistry, chemistry, engineering).
  • 8 years of experience in the biotechnology and/or pharmaceutical industry.
  • 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 inspection preparation.
  • 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 biotech companies.
  • 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 organization.
  • 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 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.

Keywords: Atara Biotherapeutics, Thousand Oaks , Sr Manager Quality Assurance - Product Complaints, Other , Thousand Oaks, California

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