Associate Director, Computer Validation Systems and Data Integrity - REMOTE
Atara Biotherapeutics
2021-10-29T20:40:37Z
Thousand Oaks
California
United States
Information Technology
(No Timezone Provided)
Job Description
We are currently recruiting for an Associate Director, Computer Validation Systems and Data Integrity who will serve as the leader for the QA CSV team and oversee Atara’s Computer System Validation/E-Compliance programs. The position will work closely with manufacturing, QC, Regulatory, Engineering, Quality Operations, Quality Control, and IT/Automation teams to ensure compliance of cGMP systems.
This individual will be responsible for software quality oversight and execution of system validation and verification efforts supporting computerized systems (including equipment/instruments with a computer component) ensuring compliance to quality objectives and regulatory requirements.
Work Location Thousand Oaks, CA OR Remote
Reports to Director, Validation
Travel Up to 10%
Responsibilities:
Provide QA and validation leadership for GXP computerized systems and applies risk-based methodology to validation/qualification efforts in compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5. Oversee the overall readiness of the CSV and Data Integrity programs to ensure programs are compliant and ready for regulatory inspections. Oversee and execute software QA and validation strategy in support of custom software systems, COTS configuration, workflow, and/or analytics to improve the overall accuracy, efficiency, and effectiveness of the electronic computerized system. Assess systems for data integrity and compliance with regulatory expectations including assessment of third-party IT service suppliers and applications. Manage and provide guidance to CSV group in the organizing and prioritizing daily tasks, performing training, and writing performance reviews. Effectively identify and resolve complex system issues and appropriately communicates gating items to senior management and stakeholders. Review/assess proposed validated system changes via CAPA, Change Control and Work Orders to identify requirements necessary to maintain validated status. Participate and support the external audit program for vendors related to GXP computerized systems. Participate and be the Software QA and Computer system validation SME in cross-functional project teams. Evaluate and recommend QA process changes by keeping abreast of the requirements for compliance in own area of work.
Qualifications
B.S. degree in Computer Science or related field 10+ years of relevant progressive experience, preferably within the pharmaceutical/biotech industry 5 years of supervisory/personnel management experience. Comprehensive expertise and working knowledge of GxP, 21 CFR Parts 11, Annex 11 and Data Integrity compliance requirements. Experience in providing oversight in implementing and maintaining GXP computer systems in a validated state. Experience with the following types of computerized systemsERPLIMSQuality Management System (QMS)Learning Management System (LMS)Manufacturing Execution System (MES)Manufacturing automation systems.QC Laboratory Software and Instrumentation Strong working knowledge in validation methodology (including GAMP) and software development life cycle (SDLC) principles. Proven experience managing software validation teams. Excellent verbal, written and interpersonal communication skills. Effective time management and interpersonal skills Strong organizational skills, planning skills and must work effectively within teams. Work effectively within teams with rapidly changing priorities. Able to independently represent the QA organization in a wide assortment of situations. Knowledge of and the ability to implement 21 CFR Part11 and EU Annex 11 compliance. Thorough understanding of industry standards and best practices for Good Engineering Practices and validation such as GAMP 5 and ASTM E2500. Flexibility to travel as required to accommodate business needs. Able to work in controlled manufacturing environments requiring special gowning. Able to work in computer system/IT room environments. Role model for Atara TRAIT values (Transparency, Respect, Accountability, Integrity, Trust)
Associate Director, Computer Validation Systems and Data Integrity - REMOTE
Job Description
We are currently recruiting for an Associate Director, Computer Validation Systems and Data Integrity who will serve as the leader for the QA CSV team and oversee Atara’s Computer System Validation/E-Compliance programs. The position will work closely with manufacturing, QC, Regulatory, Engineering, Quality Operations, Quality Control, and IT/Automation teams to ensure compliance of cGMP systems.
This individual will be responsible for software quality oversight and execution of system validation and verification efforts supporting computerized systems (including equipment/instruments with a computer component) ensuring compliance to quality objectives and regulatory requirements.
Work Location Thousand Oaks, CA OR Remote
Reports to Director, Validation
Travel Up to 10%
Responsibilities:
Provide QA and validation leadership for GXP computerized systems and applies risk-based methodology to validation/qualification efforts in compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5. Oversee the overall readiness of the CSV and Data Integrity programs to ensure programs are compliant and ready for regulatory inspections. Oversee and execute software QA and validation strategy in support of custom software systems, COTS configuration, workflow, and/or analytics to improve the overall accuracy, efficiency, and effectiveness of the electronic computerized system. Assess systems for data integrity and compliance with regulatory expectations including assessment of third-party IT service suppliers and applications. Manage and provide guidance to CSV group in the organizing and prioritizing daily tasks, performing training, and writing performance reviews. Effectively identify and resolve complex system issues and appropriately communicates gating items to senior management and stakeholders. Review/assess proposed validated system changes via CAPA, Change Control and Work Orders to identify requirements necessary to maintain validated status. Participate and support the external audit program for vendors related to GXP computerized systems. Participate and be the Software QA and Computer system validation SME in cross-functional project teams. Evaluate and recommend QA process changes by keeping abreast of the requirements for compliance in own area of work.
Qualifications
B.S. degree in Computer Science or related field 10+ years of relevant progressive experience, preferably within the pharmaceutical/biotech industry 5 years of supervisory/personnel management experience. Comprehensive expertise and working knowledge of GxP, 21 CFR Parts 11, Annex 11 and Data Integrity compliance requirements. Experience in providing oversight in implementing and maintaining GXP computer systems in a validated state. Experience with the following types of computerized systemsERPLIMSQuality Management System (QMS)Learning Management System (LMS)Manufacturing Execution System (MES)Manufacturing automation systems.QC Laboratory Software and Instrumentation Strong working knowledge in validation methodology (including GAMP) and software development life cycle (SDLC) principles. Proven experience managing software validation teams. Excellent verbal, written and interpersonal communication skills. Effective time management and interpersonal skills Strong organizational skills, planning skills and must work effectively within teams. Work effectively within teams with rapidly changing priorities. Able to independently represent the QA organization in a wide assortment of situations. Knowledge of and the ability to implement 21 CFR Part11 and EU Annex 11 compliance. Thorough understanding of industry standards and best practices for Good Engineering Practices and validation such as GAMP 5 and ASTM E2500. Flexibility to travel as required to accommodate business needs. Able to work in controlled manufacturing environments requiring special gowning. Able to work in computer system/IT room environments. Role model for Atara TRAIT values (Transparency, Respect, Accountability, Integrity, Trust)