IT CSV Manager

Our IT CSV Manager (Computer Systems Validation) (IT-CSV), plays a vital role within our organization. Once you complete our training, this role will be responsible for the strategy and implementation of the IT Computer System Validation and Quality Assurance program for GxP-regulated IT systems. This individual will oversee the validation and continued compliance of the IT systems and processes. Additionally, this individual will be responsible for the IT GxP Training program. At Quva, you will be an essential part of a mission-driven organization dedicated to expanding critical access to quality, affordable medication and data insights while promoting a culture of innovation, collaboration, and continuous improvement. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US., * 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

Do you have experience in Validation design?, Do you have a Bachelor’s degree?, * Has a sense of urgency, accountability, and resourcefulness (e.g., work in a changing environment)

• Is a self-starter and independent learner
• Promotes active listening with team members; Contributes appropriately to conversations; Has strong verbal and written communication skills with the ability to work effectively with other departments within the organization and with people at all levels of the organization
• Understands how various issues affect each other and the outcome of projects; Improves upon existing approaches by seeking opportunities to creatively transform
• Has natural curiosity to take on new challenges, responsibilities, and gain business knowledge, * 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; Experience with computer system validation across manufacturing operations, ERP systems, Quality Lab systems
• 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

Pulled from the full job description

• Health insurance
• 401(k) matching
• Vision insurance
• Dental insurance
• Paid holidays
• Opportunities for advancement, Benefits of Working at Quva:
• Set, full-time, consistent work schedule
• 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
• National, industry-leading high growth company with future career advancement opportunities

Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma’s multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva’s overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care.