Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:
This position will be supporting ongoing plasma systems and applications used across regulated plasma operations. This individual will work with IT, Quality, business process owners, and project teams to ensure system changes, enhancements, and releases are appropriately assessed, tested, documented, and approved in accordance with CSA principles and applicable regulatory requirements. The ideal candidate is a senior-level CSA/CSV professional who can independently manage validation activities within a regulated plasma environment and quickly integrate into an established team and operating model.
Job Responsibilities:
• Lead and execute CSA activities for computerized systems supporting Plasma operations.
• Support validation of system changes, enhancements, integrations, configurations, and releases within the Plasma functional area.
• Assess system and change risk and define the appropriate CSA strategy, testing approach, and level of documentation.
• Develop and/or review CSA deliverables including risk assessments, validation plans, requirements, test strategies, test scripts, traceability, summary reports, and change control documentation.
• Apply risk-based CSA principles based on intended use, process impact, donor impact, data integrity, and system criticality.
• Partner with IT, Quality, business process owners, technical teams, and other stakeholders throughout the system lifecycle.
• Support test execution, defect and deviation management, documentation review, and release readiness activities.
• Review system integrations, interfaces, data flows, and configuration changes as applicable.
• Ensure validation activities align with applicable procedures, quality system requirements, and regulatory expectations.
• Provide practical CSA guidance to project teams and help determine appropriate evidence and testing rigor based on risk.
• Manage assigned CSA activities independently and ensure deliverables progress through review and approval according to project timelines.
Required Experience:
• Senior-level CSV/CSA experience within life sciences, biotechnology, pharmaceutical, plasma, blood products, or another regulated environment.
• Strong understanding of GxP computerized systems, Computer Software Assurance, and risk-based validation principles.
• Experience supporting regulated application changes, enhancements, integrations, and releases.
• Ability to assess system risk and independently define and execute an appropriate validation strategy.
• Strong experience with requirements, risk assessments, test planning, test execution, traceability, deviation management, validation reporting, and release readiness.
• Experience working cross-functionally with IT, Quality, business process owners, and technical teams.
• Ability to operate independently within an established program and manage multiple concurrent validation activities.
Preferred Experience:
• Direct experience supporting Plasma or blood products systems and business processes.
• Experience with applications supporting donor management, donor operations, plasma collection, or related regulated processes.
• Experience with system integrations, interfaces, data flows, master data, or reporting within a regulated environment.
• Familiarity with 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity expectations, and risk-based assurance practices.
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
*Verista is an equal opportunity employer.
Benefits
Why Choose Verista?
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For more information about our company, please visit us at Verista.com
Verista is a leading business and technology consultancy firm that provides systems, compliance, validation and quality solutions to life science companies - enabling them to improve health and improve lives. We help clients solve their most critical and complex challenges across the GxP lifecycle, from preclinical and clinical to commercialization, manufacturing and distribution – bringing together decades of knowledge, the most advanced engagement platforms and transformative technologies. This allows clients to benefit from the ease, efficiency and trust that results from working with one partner who excels across specialties. Verista’s clients trust the company’s 650+ experts to deliver consistent, safe, and high-quality results across the product development lifecycle. Verista is based in Fishers, Indiana, Wayne, Pennsylvania, Westford, Massachusetts, and San Mateo, California. For more information, visit www.verista.com
