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

Remote Manager, Computer System Validation (CSV)

Alimentiv • Brampton, 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) • Brampton, 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

Senior Computer Vision Engineer

Birdseye Solutions IncMississauga
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

Enterprise Customer Success Manager - CAD $120,000 – CAD $132,000 / year - Canada (Remote working)

SuperstarsMississauga, Peel Region, CA
Remote
Full-time

Enterprise Customer Success Manager - CAD $120,000 – CAD $132,000 / year - Canada (Remote working).This range is provided by Superstars.Your actual pay will be based on your skills and experience —... 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

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

Engineering Manager, Data and ML - (Remote - Canada)

JobgetherMississauga, Peel Region, CA
Remote
Full-time

Engineering Manager, Data and ML - (Remote - Canada).Be among the first 25 applicants.Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talen... Show more

 • Promoted

Verification and Validation Engineer

Vital BioOakville, Ontario, Canada
Full-time

About You: You possess excellent problem‑solving skills and approach every problem with a friendly and positive attitude.You are self‑motivated, possess a high level of autonomy, and enjoy working ... Show more

 • Promoted

Manager, Application Support

Echelon 56Vaughan
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

Remote Enterprise Solutions Engineering Manager (Canada)

VerkadaMississauga, Peel region, Canada
Remote
Full-time

A leading security technology company is seeking an Enterprise Solutions Engineering Manager in Canada.This remote position requires a technical leader with at least 3 years of experience managing ... Show more

 • Promoted

Industrial Software Validation

Husky Injection Molding Systems Ltd.Bolton, Canada
Full-time

Range $100,000 - $120,000 Software Validation Specialist The Software Validation Specialist plays a key role in our Innovation and Sustainability Team, responsible for developing and executing com... Show more

 • Promoted

Remote ICT & ISO Solutions Sales Manager

ATIA LtdBrampton, Peel Region, CA
Remote
Full-time

A multinational information systems company is seeking a sales strategist to shape marketing initiatives and find potential customers.Ideal candidates will have over 5 years of experience, includin... 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

Business System Analyst

Open Systems TechnologiesMississauga
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

Senior Lead Clinical Data Manager - Remote Canada

Warman O'BrienMississauga, Peel region, Canada
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

Remote-First Technical Support Manager: Lead & Elevate

commonskuMississauga, Peel region, Canada
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

System Completions Coordinator

LycopodiumMississauga, Peel Region, CA
Full-time

With offices in Australia, Canada, USA, Southern Africa, Ghana, Philippines, Argentina and Peru, Lycopodium proudly delivers high quality professional engineering and project delivery services glob... Show more

 • Promoted

Senior Verification Manager, SERDES PHY

Synopsys, Inc.Mississauga, Ontario, Canada
Full-time

We Are 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... Show more

 • Promoted

HCM System Specialist

Chartwell Retirement ResidencesMississauga
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

Validation Specialist

Axiomatic Technologies CorporationMississauga
Full-time

This is a full-time on-site Validation Specialist role located in Mississauga, ON.The Validation Specialist will be responsible for performing and overseeing computer system validation and process ... Show more