IT CSV Manager

ManagerManagerFull TimeRemoteSeniorTeam 1,001-5,000Since 2015H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

3 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

IT CSV Manager

Quva

• Develops the Computer System Validation strategy for IT systems supporting GxP business processes throughout the complete system lifecycle • Collaborates with the Corporate/Clinical Quality Assurance in the development, implementation and execution of CSV process and procedures • Develops Standard Operating Procedures and Work Instructions for the complete system lifecycle, including Risk Management, Computer System Validation, and Change Control • Partners with System/Process Owners to implement and maintain GxP computerized systems in a validated state and in accordance with regulatory agency regulations and internal requirements • Manages and oversees validation of IT GxP systems • Manages the change control process across all the IT GxP systems • Collaborates with Corporate QA for IT system vendor audit and qualification • Represents IT during internal and external agency audits and inspections • Develops IT CSV Training program and manages compliance of the training program for applicable IT team members

Job Requirements

  • Bachelor’s degree in information technology, or related field, required
  • 5 -7 years of experience in developing and implementing computer system validation, data integrity, and quality practices;
  • Excellent understanding of the CFR Part 11 and Annex 11 regulations for computer systems
  • Collaborative skills in working with a wide range of users including Corporate Quality Assurance to develop Computer System Validation program
  • Experience with educating and training users at different levels on the computer system validation process and practices
  • Experience with planning and scheduling the timely completion of system validation projects
  • 18+ years of age
  • Able to successfully complete a drug and background check
  • Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas.

Benefits

  • Comprehensive health and wellness benefits including medical, dental and vision
  • 401k retirement program with company match
  • 22 paid days off plus 8 paid holidays per year
  • Occasional weekend and overtime opportunities with advance notice

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