Software Quality CSV Lead in Redwood City, CA at Johnson Service Group

Date Posted: 9/12/2022

Job Snapshot

Job Description

JobID: 390433

Johnson Service Group is looking for a Quality Computer Systems Validation (CSV) Lead.  The Quality Computer Systems Validation Lead is responsible for Quality oversight and management of GxP Computer System Validation (CSV) activities in accordance with industry standards and regulatory guidance to ensure the systems are appropriately validated prior to release and remains in a compliant state throughout the lifecycle. The position will be a point of contact managing internal resources and represent Celito Tech with both internal and external stakeholders.

Responsibilities and Duties

  • Provide leadership and guidance to Celito Tech personnel on CSV projects and ensure compliance to applicable industry regulations
  • Work collaboratively across functions with Quality, IT, Business partners, and Vendors to plan, coordinate, and execute CSV activities utilizing a risk-based approach
  • Authoring, review, and approval of CSV deliverables including but not limited to vendor assessments, change controls, system risk assessments, validation plans, user and or functional requirements specification, configuration specifications, IQ/OQ/PQ protocols, traceability matrix, summary reports and applicable SOPs (System Administration and User/Operation)
  • Oversee formal test execution to ensure the testing was performed appropriately and the test results are compiled in a timely manner
  • Maintaining the validated state of internal and client supported GxP systems including periodic review and release management based on continuous cloud assurance model
  • Provide Quality oversight and approval of periodic user access and audit trail reviews


• Contributes to the QMS software development including process definition/design, system review and development testing for functionality and User Interface (UI) as well as validation, training, and system support documentation

Qualifications

• Bachelor’s degree in life sciences or engineering and 10 years of related experience; or equivalent combination of education/training and experience

  • Additionally, 5-10+ years of direct validation responsibilities in GxP Quality, Computer Systems Validation experience
  • Experience in performing validation of cloud-based Computer solutions and continuous cloud assurance program
  • A strong knowledge of procedures and best practices related to FDA Regulations, 21 CFR Part 11, Computer System Validation, GAMP 5, GxP (GLP, GCP, GMP, and GVP) practices
  • Ability to communicate regulations and requirements to teams and clients
  • Experience with validation of Quality Management Systems (QMS) such as Veeva Vault, ZenQMS, or MasterControl, including Electronic Document Management Systems (eDMS), Clinical Systems, Learning Management Systems (LMS), and/or Laboratory Information Management Systems (LIMS) is required
  • Knowledge of QMS processes including: Controlled Document Management, Learning Management (Training), Deviation/Event Investigation, Corrective and Preventive Action (CAPA), Change Control Management, and Audits and Inspections
  • Able to multi-task and work cross-functionally
  • Works with various clients, vendors and team members to ensure project/program goals are met
  • Strong written and oral communication skills, able to translate complex concepts across all levels of the organization

#D800

•* Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.




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