IT CSV Manager

🔥 7 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

Apply Now

Find Similar Remote Jobs

Receive Emails For Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Quva

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2015

💊 Pharmaceuticals

🤖 Artificial Intelligence

☁️ SaaS

Pharmaceuticals • Artificial Intelligence • SaaS

Quva is a combined pharmaceutical manufacturer and health-system pharmacy analytics company that produces high-quality, sterile ready-to-administer (RTA) injectable compounded medications and delivers AI-powered data and analytics solutions for hospitals and health systems. Quva Pharma operates 503B sterile outsourcing and forward distribution capabilities to supply thousands of U. S. hospitals, while Quva BrightStream (formerly LogicStream Health) provides a SaaS platform that ingests disparate clinical and operational data to deliver predictive insights and tools such as shortage navigation, diversion surveillance, supply optimization, revenue capture, contract compliance, and clinical process optimization. The company emphasizes quality, regulatory-compliant manufacturing, distribution reliability, and data-driven solutions to improve pharmacy operations, reduce shortages and errors, and drive better patient and financial outcomes.

📋 Description

• 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