IT CSV Manager
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
IT CSV Manager overseeing the strategy and compliance of validation for GxP-regulated IT systems in a remote setup. Contributing to a mission-driven organization focused on healthcare access and data insights.
Responsibilities:
- 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
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
Similar Jobs
Manager, AP/AR
AP/AR Manager overseeing finance operations at General Dynamics Ordnance and Tactical Systems. Preparing and analyzing accounts payable/receivable transactions with team supervision.
Care Team Manager
Manager leading and developing a team of Health Pros at Alight Solutions. Responsible for operational processes and meeting quality standards within a flexible workspace.
IT Portfolio Manager
TI Portfolio Manager managing strategic portfolio of projects in a manufacturing setup. Ensuring alignment between business objectives and IT deliverables while improving operational efficiency.
Market Development Manager
Market Development Manager at Secura Bio, capturing KOL insights to inform oncology brand strategy. Collaborating with cross-functional teams to identify marketing opportunities.
Senior Manager, Pretzels & Bold Snacking Brand
Senior Manager leading brand equity and activation marketing for Dot’s Pretzels within The Hershey Company. Driving brand relevance and sales growth with a strategic, consumer-first approach.
Distributor – Market Development Manager
Distributor & Market Development Manager at Insulet driving sustainable growth through distributor partnerships. Collaborating across cross-functional teams to enhance commercial strategies and patient outcomes.
Operational Business Management, Manager
Operational Business Management Manager at Amgen supporting budget forecasting and resource capacity planning activities. Collaborating with stakeholders to ensure operational efficiency and financial discipline in global operations.
Associate Site Activation Manager
Associate Global Site Activation Manager overseeing site activation for clinical trials. Leading country operations teams to ensure timely client commitments and execution of global activation strategies.
Democracy Defense Manager
Democracy Defense Manager with All Voting is Local, focusing on defending election integrity in Arizona. Leading coalitions, managing campaigns, and addressing threats to voting rights.
Interim Senior Learning and Evaluation Manager – Short-Term Consultancy
Interim Senior Learning and Evaluation Manager supporting Global Fund for Children with outcomes management and evaluation. Engaging with community-based organizations to enhance the lives of children and youth globally.
Family Offices Services Manager
Family Office Services Manager leading investment services delivery for ultra-high-net-worth client families. Managing capital and constructing portfolios while coordinating with wealth management advisors.
Senior UA Manager, Core, TikTok
Senior UA Manager responsible for TikTok UA across dating portfolio. Join social discovery group improving connection on a global scale.
Senior UA Manager, Core
Senior UA Manager overseeing Facebook user acquisition for dating portfolio. Focus on campaign management, scaling, and automation improvements across web funnels with a B2C approach.
Senior Contract Manager
Senior Contracts Manager responsible for U.S. Government contracts at GE Aerospace. Ensuring compliance and effective contract management across all phases of contract lifecycle.
Senior Manager, Deployment
Senior Manager responsible for leading telecommunications deployment initiatives and cross-functional teams. Ensuring project delivery aligns with carrier standards and business goals.
Projektmanager, m/w/d
Project Manager leading healthcare software projects for Dedalus, ensuring client-focused delivery and team coaching. Requires strong analytical skills and project management experience in the healthcare sector.
General Ledger Manager
General Ledger Manager at Milliman overseeing GL team management and financial reporting responsibilities. Collaborating with finance teams for journal entry preparation and process enhancements.
Manager, Records Management – LATAM
Manager of Clinical Systems responsible for building Records Management team in LATAM. Overseeing TMF processes and ensuring compliance in clinical trials documentation.
Manager, Records Management – LATAM
Manager of Clinical Systems overseeing Records Management team across LATAM for Precision for Medicine. Responsible for quality assurance and support duties with a focus on compliance.
Manager, Case Management – RN License Required
Manager overseeing high-performing case management team for Medicare Advantage SNP at Alignment Health. Driving compliance and quality care outcomes for members with complex healthcare needs.