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Sr. IT Manager

Menlo Park, CA

Posted: 02/21/2023 Position Categories: Technology Pay Rate: 136,000 - 195k

Job Description

A pharmaceutical company is seeking a Senior IT Manager to join their team!
Summary: Reporting to the Director, Information Technology the Manager, Computer Systems Validation (CSV) will be a core member of the Information Technology team and responsible for the implementation, management, ongoing support and review of company’s internal GXP validated systems. This individual will ensure IT Quality and Risk Management standards are defined, understood, designed into work activity and achieved. This individual will manage day-to-day operations for IT Compliance and Risk Management, working closely with key stakeholders from business teams, particularly QA, heavily guiding business teams on validation principals and requirements throughout the system lifecycle. This role will ensure compliance risks are identified, mitigated and managed appropriately
  • 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

Preferred Education and Experience
  • 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
Skills, Qualifications, or Technical Proficiencies
  • 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.

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