Talent.com
Alimentiv
Remote Manager, Computer System Validation (CSV)Alimentiv • Burlington, Ontario
Remote Manager, Computer System Validation (CSV)

Remote Manager, Computer System Validation (CSV)

Alimentiv • Burlington, Ontario
30+ days ago
Job type
  • Full-time
  • Remote
Job description
As Manager/Senior Manager, Computerized System Validation, you will lead the transformation of CSV practices within a dynamic contract research organization. Leveraging deep expertise in global regulatory requirements, including FDA, EMA, GCP, and ICH guidelines, you will ensure validation processes are risk-based, efficient, and compliant. You will be responsible for interpreting and applying these regulations pragmatically to both off-the-shelf and custom-developed software solutions, enabling agile software delivery while maintaining the highest standards of quality and compliance. This role requires a collaborative leader who partners effectively with Technology, Product, Quality, and operational teams, advocates for practical and common-sense solutions, and drives continuous improvement in technology and clinical research operations.

Responsibilities

    • The Manager/Senior Manager, CSV will be responsible for the following:

      • Computerized System Validation Leadership
    • Develop, implement, and continuously refine risk-based CSV strategies for both off-the-shelf and custom-developed software, ensuring alignment with FDA, EMA, GCP, and ICH guidelines.
    • Oversee the full lifecycle of validation activities, including planning, execution, documentation, and maintenance, with a focus on integrating CSV into agile software development processes.
    • Ensure validation deliverables such as risk assessments, validation plans, protocols, test cases, and traceability matrices are prepared to the highest standards of quality and regulatory compliance.
    • Monitor and interpret changes in global regulatory requirements, proactively updating internal policies and procedures to maintain compliance and operational excellence.
    • Utilize technology to drive operational efficiencies into the CSV process.

      • Regulatory Compliance and Quality Assurance
    • Serve as the subject matter expert on regulatory requirements for computerized systems supporting clinical research, providing guidance on the practical application of regulations to diverse technology solutions.
    • Collaborate closely with Quality to identify, assess, and remediate compliance gaps, ensuring all systems meet GCP and other relevant standards.
    • Lead the preparation and submission of documentation for regulatory inspections, audits, and sponsor audits, ensuring timely and accurate responses to findings and observations.

      • Cross Functional Collaboration and Stakeholder Engagement
    • Act as a strategic partner to corporate IT, Product, software development, Quality, and operational teams, facilitating the integration of CSV requirements into business processes and technology projects.
    • Advocate for pragmatic, risk-based approaches that balance regulatory compliance with business agility and innovation.
    • Design and deliver training programs to build organizational capability in CSV principles, regulatory requirements, and best practices.

      • Team Management & Development
    • Lead, mentor, and develop a team of validation specialists, fostering a culture of collaboration, accountability, and continuous improvement.
    • Ensure the team is appropriately resourced, trained, and equipped to deliver on validation objectives and support organizational growth.
    • Conduct regular performance reviews, set clear goals, and provide constructive feedback to support professional development and high performance.

      • Audit & Inspection Support
    • Represent the CSV function during internal and external audits, regulatory inspections, and sponsor reviews.
    • Coordinate the investigation and resolution of audit findings, ensuring corrective and preventive actions are implemented effectively and sustainably.
    • Maintain readiness for audits by ensuring documentation, processes, and systems are consistently compliant and up to date.

Qualifications

    • 7-9 years minimum experience in Computerized System Validation in a CRO environment
    • Extensive experience in Computer System Validation (CSV) within GxP environments, ideally in a CRO, pharmaceutical, or biotech setting.
    • Deep knowledge of regulatory frameworks such as 21 CFR Part 11, GAMP 5, EU Annex 11, and data integrity principles.
    • Strong understanding of clinical trial processes, electronic systems (e.g., CTMS, eTMF, EDC), and their validation requirements.
    • Proven ability to lead validation projects, manage cross-functional teams, and oversee vendors or third-party system providers.
    • Excellent communication skills for translating technical requirements into clear guidance for non-technical stakeholders.
    • Advanced problem-solving and risk-assessment capabilities for determining appropriate validation scope and strategies.
    • Experience preparing for and supporting regulatory inspections, sponsor audits, and internal quality reviews.
    • Strong organizational and project-management skills, including the ability to manage multiple global initiatives simultaneously.
$89,000 - $148,000 a year+ bonusWe may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Create a job alert for this search

Remote Manager, Computer System Validation (CSV) • Burlington, Ontario

Similar jobs

BAS System Designer

Ainsworth Incmississauga, peel region, Canada
Full-time

We are currently seeking a highly energetic and organized individual to work in our System Application-Design Department as a System Designer with emphasis on BAS system design.Involved with projec... Show more

 • Promoted

Manager, Application Support

CAA Club GroupVaughan, York Region, CA
Full-time

At CAA Club Group, we are passionate about keeping our Members safe—whether they are on the road, at home, or traveling abroad.As a trusted member‑based organization, we provide products and servic... Show more

 • Promoted

Remote Senior Information System Analyst for SAP BW Optimization

Cpus Engineering Staffing Solutions Inc.Mississauga
Remote
Full-time

Become a key player in SAP BW operations as a Senior Information System Analyst.Collaborate remotely to enhance HR and Finance reporting, ensuring seamless SAP BW functionality.In this senior role,... Show more

 • Promoted

Application Support Manager with CAA

CAA Club GroupVaughan, York Region, CA
Full-time

Exciting opportunity as Application Support Manager at CAA Club Group, focusing on Roadside and Travel services.Leverage your skills to enhance operational efficiency and member satisfaction.You wi... Show more

 • Promoted

Systems Integrator II

Ulteig EngineersBurlington, Ontario, Canada
Full-time

The System Integrator II is responsible for programming and commissioning control systems that bring together multiple sub-systems to meet the operational and regulatory needs of the owner.The Syst... Show more

 • Promoted

Senior Computer Vision Engineer (Remote – Flexible)

Birdseye Solutions IncMississauga, Peel Region, CA
Remote
Full-time

An established industry player is seeking an innovative AI Engineer to join their dynamic team.This role offers the chance to design cutting-edge AI algorithms for the site-monitoring industry, inc... Show more

 • Promoted

System Wayside and OM Manager

Alberici ConstructorsBurlington, Halton Region, Canada
Full-time

The System Wayside and O&M Manager is responsible for leading the design, engineering, and integration of wayside systems and ensuring Operations & Maintenance (O&M) readiness across the ECWE proje... Show more

 • Promoted

Senior Lead Clinical Data Manager - Remote Canada

Warman O'BrienMississauga, Peel Region, CA
Remote
Full-time

A leading pharmaceutical firm is seeking a Senior Lead Clinical Data Manager to drive data strategy and lead high-impact clinical projects fully remotely in Canada.The role requires extensive exper... Show more

 • Promoted

HCM System Specialist

Chartwell Retirement ResidencesMississauga, Peel Region, CA
Full-time

Chartwell Retirement Residences.Direct message the job poster from Chartwell Retirement Residences.Reporting to the Manager Information Systems, HCM, this role will require technical skills in the ... Show more

 • Promoted

Sales Manager for Innovative Software and Information Solutions

ATIA LtdMississauga, Peel region, Canada
Full-time

Transform your career as a Sales Manager, specializing in innovative software and information systems.Work from home while crafting effective strategies to forge new partnerships.With a minimum of ... Show more

 • Promoted

System design & Validation, Principal Engineer- 15024

Synopsys IncMississauga
Full-time

At Synopsys, we drive the innovations that shape the way we live and connect.Our technology is central to the Era of Pervasive Intelligence, from self‑driving cars to learning machines.We lead in c... Show more

 • Promoted

Senior Computer Vision Engineer

Birdseye Solutions IncMississauga, Peel Region, CA
Full-time

Birdseye’s mission is to help make the world a safer place!.We are the leader in AI-driven Remote Facility Supervision solutions for the Trucking and Logistics Industry.Our Maximum Telepresence App... Show more

 • Promoted

Manager, Software Development & Verification - C$111,333 - C$122,500 A Year

SciexVaughan, Canada
Full-time

Leads a software verification team to ensure high-quality, reliable software releases for life sciences and diagnostics products.Manages verification strategy, partners with development and quality... Show more

 • Promoted

Sales Manager for Information Systems

ATIA LtdMississauga, Peel Region, CA
Full-time

ATIA Holding is hiring a Sales Manager to establish sales strategies for its information systems and applications.Enjoy a work-from-home model along with project-based compensation and professional... Show more

 • Promoted

Business System Analyst

Open Systems TechnologiesMississauga, Peel Region, CA
Full-time

The ideal candidate will require a foundational knowledge of Data Governance practices as well as Data Quality principles, along with a practical knowledge of how to evaluate existing controls, ide... Show more

 • Promoted

System Validation Engineer at Evertz

Evertz Microsystems LimitedBurlington, Halton Region, CA
Full-time

Become a System Validation Engineer at Evertz Microsystems, focusing on robust technical support and system testing in a thriving company.Harness your expertise in hardware and software validation.... Show more

 • Promoted

Remote-First Technical Support Manager: Lead & Elevate

commonskuMississauga, Peel Region, CA
Remote
Full-time

A leading software company in Canada is seeking a Technical Support Manager to lead their support function.This role involves both management of a support team and hands-on technical troubleshootin... Show more

 • Promoted

Manager, Application Support

Echelon 56Vaughan, York Region, CA
Full-time

Develop and adhere to service level agreements (SLA’s) for Roadside and Travel requests.Assess and support existing production systems and applications and give recommendations on how to maximize p... Show more

 • Promoted

Results-Oriented Sales Manager for Information Systems and Solutions

ATIA LtdOakville, ON, CA
Full-time

Lead the charge in sales as a Sales Manager focusing on innovative information systems.Design strategies for marketing, cultivate client relationships, and communicate effectively with management w... Show more

 • Promoted

Senior Verification Manager, SERDES PHY

Synopsys, Inc.Mississauga, Peel Region, CA
Full-time

Synopsys is the leader in engineering solutions from silicon to systems, enabling customers to rapidly innovate AI-powered products.We deliver industry-leading silicon design, IP, simulation and an... Show more