Atara Biotherapeutics, Inc. Sr. Manager, Validation in Thousand Oaks, California
The Senior Manager, Validation will lead and oversee the site validation team responsible for the qualification of Equipment, Utilities, Facilities. The Sr. Manager will work closely with Manufacturing, QC, Engineering and Facilities group to ensure compliance of cGMP systems.
Work Location Thousand Oaks, CA
Reports to Associate Director, Validation
Travel Up to 10%
Oversee development and implementation of validation strategies, policies, protocols, and other documentation for cGMP systems including:
Quality Control Equipment
Supervise staff and validation contractors in the planning and execution of validation activities.
Review and approve validation documents generated by team.
Develop and execute validation plans and protocols to demonstrate systems are meeting design and functional requirements.
Perform analysis and compilation of data and results into summary and final reports.
Develop, organize, and execute the Validation Maintenance (Requalification) program.
Evaluating and performing periodic reviews of validated systems to ensure validated state in maintained.
Review/assess proposed validated system changes via CAPA, Change Control and Work Orders to identify requirements necessary to maintain validated status.
Work with QA to investigate system issues and perform root cause analysis and implement solutions.
As a subject matter expert, represent these activities in discussions and communications with regulatory agencies (e.g., strategizing and preparation of regulatory submissions and in response to agency questions, as well as during facility inspections).
Interface with other departments (e.g., IT, Engineering, Facilities, Manufacturing, Regulatory Affairs, Quality Control and Quality Assurance) to ensure achievement of Atara’s objectives relating to validation and associated activities; including compliance with all applicable standards.
Bachelor’s Degree in Engineering, Computer Science, or related science.
8+ years of experience or an equivalent combination of education and experience.
At least 1 year of supervisory/personnel management experience.
Broad validation experience in the pharmaceutical industry supporting cGMP facilities, equipment, and utilities.
Experience leading projects with history of achieving results and outstanding outcomes.
Direct experience participating and supporting regulatory inspections and submissions.
Experience validated manufacturing equipment, critical utilities, facilities, and QC equipment.
Experience with Aseptic processing and filling equipment.
Proven experience managing teams.
Independent decision-making capability and ability to think conceptually and understand impact of decisions critical.
Strong conflict resolution and negotiation skills required.
Proven project management skills required. Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
Excellent verbal and written communication skills; good interpersonal skills.
Independently represent the QA organization in a wide-assortment of situations
Flexibility to travel as required to accommodate business needs.
Able to work in controlled manufacturing environments requiring special gowning.
Must be able to work in computer system rooms environments.
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.
Official Title: Sr. Manager, Validation
Job ID: 2021-1551
External Company Name: Atara Biotherapeutics, Inc.
External Company URL: https://www.atarabio.com/