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Associate Director / Director Quality Assurance, Lot Disposition

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

Job Description:

Job Description

The Associate Director / Director Quality Assurance, Lot Disposition, is responsible for establishing and maintaining a robust and efficient, phase appropriate, disposition program. This position will lead a team of dedicated staff to manage the performance, quality and compliance of product disposition and to identify and drive continuous improvement. This role is instrumental in ensuring supply to patients by releasing material produced at Atara and CMO sites across both Clinical and Commercial. The Director of lot disposition will also serve as the global process owner for Disposition at Atara accountable for Disposition Policies, Standards, and procedures. This position interacts cross-functionally with Manufacturing, Supply Chain, Regulatory, Clinical Operations, Quality Control, Process Sciences, and Validation to ensure Quality objectives and initiatives are effectively delivered in a phase appropriate compliant manner.

Reports to: Sr. Director, Quality Operations

Location: Thousand Oaks, CA

Responsibilities

  • Independently perform and manage batch release activities for production including, but not limited to, review of batch records, analytical data, certificates of analysis, and other documents.
  • Build and implement foundational programs and systems to ensure all GxP requirements associated with the disposition of product batches are phase appropriate and complied with.
  • Ensure Disposition process and interdependencies are defined and well understood, and leverage data and technology to drive compliance, efficiency, and monitoring.
  • Ensure integration of Disposition process with other Quality Systems (NC/CAPA, Change Control, Validation, Jurisdictional control and Regulatory Affairs)
  • Provides guidance and quality oversight of cGMP activities supporting all material and product disposition including; raw material & starting material receipt and disposition, Viral Vector, drug critical reagent, drug substance and drug product manufacturing, labeling, batch record review, and lot disposition.
  • Provide status reports and quality metrics to support management review process
  • Performs review of data that supports regulatory submissions.
  • Establishes collaborative relationships with internal and external stakeholders to ensure timely documentations, resolution of quality issues, and implementation of effective CAPAs.
  • Partners with cross-functional teams to ensure products are delivered on time and within specification.
  • Provides direction for complex / critical deviations, CAPAs, change controls and other quality events in support of lot disposition
  • Review & approve any major/critical deviations, change proposals or other quality records, as needed, to support lot disposition
  • Serves as Disposition SME with regulators, clients, and company management
  • Periodically conducts internal assessments to ensure that systems and processes are operated in accordance with GMPS and established procedures.
  • Perform review and approval of Quality documentation such as, equipment, system, process, and method validations, qualification and validation reports, master batch records, validation master plans (VMPs), change control, risk assessments and technical reports.
  • Lead, Identify and support continuous improvement projects in collaboration with different cross functional teams to drive manufacturing reliability and enhance quality and efficiency.
  • Assists with the administration of the Quality systems, as necessary.
  • Assist QA senior management with departmental needs.
  • Performs other duties as assigned

Qualifications

  • BS degree in life sciences, business, or related field (advanced degree preferred)
  • 10 years of experience in biopharmaceutical industry (prefer experiences in both large and small company environments)
  • Experience in Aseptic Processing
  • Ability to self-manage and work effectively with internal & external stakeholders and parties, including regulatory agencies, with minimal oversight.
  • Proven ability to proactively identify and manage risks ,and actively engage staff and
  • Attention to detail with strong analytical and problem-solving skills
  • Working knowledge of manufacturing and laboratory practices
  • Provides direction and guidance to staff or teams based on organizational goals with responsibility for results, including costs, methods and staffing
  • Ability to identify, prioritize, and implement actions to continuously improve operations and systems and manage risks.
  • Must be a strong leader and cross functional team player with ability to work effectively in a fast-paced matrixed environment while managing multiple projects simultaneously
  • Must possess excellent verbal and written communication skills; good interpersonal skills.
  • Experience supporting regulatory inspections and internal/external audits
  • 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.

Keywords: Atara Biotherapeutics, Thousand Oaks , Associate Director / Director Quality Assurance, Lot Disposition, Other , Thousand Oaks, California

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