Sr. IT Manager
Menlo Park, CA US
Job Description
- Provide IT assessment/review/oversight for Enterprise / GXP computer systems validation (focus on Pharmaceutical Systems)
- Experienced in developing validation strategies and authoring validation documents such as validation master plans, data migration plans, protocols, reports, discrepancies
- Ensure compliance and the validated state of all GXP systems
- Provide validation guidance on data migration activities as needed
- Provide IT assessment and approval for GXP computer system changes
- Experience in writing and managing documents such as change control, developed/executed Validation Plans, User Requirements Specifications, Functional Specifications, Traceability Matrix, Risk Assessments, system procedures, equipment/instrument qualifications (IQ/OQ/PQ), computer validation (CSV) and process validations (PV)
- Coordinate and support vendor support release activities
- Support and provide guidance to cross-functional groups with GXP system implementation projects and ongoing validation needs including revalidation, periodic review of system controls, security, and segregation of duties.
- Responsible to manage external CSV consultants in CSV projects
- Responsible as interface between IT and QA
Job Requirements
- 8+ years of work experience in QA or Validation performing protocol review and approval associated with the implementation and maintenance of computerized systems in pharma/biotech environment
- Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Annex 11, GAMP5, ICH 10
- Thorough understanding of validation/qualification and concepts as it applies to pharmaceuticals quality systems
- Must have excellent communication skills (both oral and written including the ability to effectively communicate across organizational levels and functions
- Proficiency in the use of Veeva Quality Docs / QMS and Compliance Wire
- Experience with CTMS and Regulatory systems
- Ability to manage external software and consultant vendors
Additional Information
For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.
Richmar is an Equal Opportunity Employer.