Talent.com
Alimentiv
Remote Manager, Computer System Validation (CSV)Alimentiv • Regina, Saskatchewan
Remote Manager, Computer System Validation (CSV)

Remote Manager, Computer System Validation (CSV)

Alimentiv • Regina, Saskatchewan
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) • Regina, Saskatchewan

Similar jobs

Remote CIAM Innovation Engineer

Affirmregina, division no. 6, Canada
Remote
Full-time

Unlock your potential as a Remote CIAM Innovation Engineer, specializing in customer identity and authentication solutions.Your engineering prowess will enhance backend services that enrich account... Show more

 • Promoted

Microsoft 365 Architect - Hybrid, Regina, SK, Canada

Arctiq: Intelligent ArchitectureRegina, Division No. 6, Canada
Full-time

Arctiq is a North American professional and managed services firm built around three Centers of Excellence: Enterprise Security, Modern Infrastructure, and Platform Engineering.We help large enterp... Show more

 • Promoted

Systems Analyst

AutismservicesRegina, Division No. 6, CA
Full-time

Under the direction of the Director, Information Technology and working as part of a team, the Systems Analyst supports the delivery of ongoing operations and evolution of the information technolog... Show more

 • Promoted

Cabling Technician Role with BFG

BFG Enterprise ServicesRegina, Division No. 6, CA
Full-time

BFG seeks a Cabling Technician dedicated to installing and maintaining network infrastructure across Canada.This role is pivotal in ensuring efficient communication systems in various settings.In t... Show more

 • Promoted

Senior Guidewire BillingCenter Developer - Remote Canada

New Value SolutionsRegina, Division No. 6, CA
Remote
Full-time

A national IT consulting company is looking for a Guidewire Senior Developer to enhance BillingCenter solutions for a public-sector insurance client.The ideal candidate will have 5+ years of Guidew... Show more

 • Promoted

Systems Analyst Role at Regina Public Library

AutismservicesRegina, Division No. 6, CA
Full-time

Enhance your career by becoming a Systems Analyst at Regina Public Library.Support and evolve IT systems and services that enhance customer experience and library operations.As part of the Informat... Show more

 • Promoted

Controls, Building Systems & Integrated Testing Lead

Alessi Search GroupRegina, SK, Canada
Full-time
Quick Apply

CONTROLS, BUILDING SYSTEMS & INTEGRATED TESTING LEAD.We are seeking a Controls, Building Systems & Integrated Testing Lead to own commissioning of control systems and the fully integrated b... Show more

Manager, Inpatient Care, 4c & Neurosciences - Pasq

AutismservicesRegina, Division No. 6, CA
Full-time

Manager, Inpatient Care, 4c & Neurosciences - Pasq.Salary and benefits as per terms and conditions of employment.The Manager, Inpatient Care is a key leader in Saskatchewan health care, partnering ... Show more

 • Promoted

Calgary AI-Driven Solution Specialist

Stantec Consulting International Ltd.Regina, Division No. 6, CA
Full-time

Play a pivotal role in water sustainability as a Solution Specialist in Calgary, enhancing AI-driven project delivery.Engage with innovative tools that improve community workflows and resource mana... Show more

 • Promoted

Strategic Information Systems Analyst & Security Architect

Gambling OddsRegina, Division No. 6, CA
Full-time

A leading tech company in Canada is seeking a skilled Information Systems Analyst to manage the full lifecycle of information systems.Responsibilities include systems analysis, security oversight, ... Show more

 • Promoted

Senior Microsoft 365 Architect Regina SK

Arctiq: Intelligent ArchitectureRegina, Division No. 6, CA
Full-time

Join Arctiq as a Senior Microsoft 365 Architect in Regina, SK, focusing on end-to-end solutions in a hybrid work environment.Drive design, migration, and governance for enterprise-wide M365 initiat... Show more

 • Promoted

Remote Containerization & Kernel Virtualisation Engineer

CanonicalRegina, Division No. 6, CA
Remote
Full-time

A leading open source software provider is seeking a skilled software engineer to focus on virtualisation and container technologies.The role requires strong skills in Go, Rust, or C/C++, along wit... Show more

 • Promoted

Senior Ciam Software Engineer

AffirmRegina, Canada
Full-time

Affirm is reinventing credit to make it more honest and friendly, giving consumers the flexibility to buy now and pay later without any hidden fees or compounding interest.Affirm is building the ne... Show more

 • Promoted

TVET Digitalization Advisor

Cuso InternationalRegina, Saskatchewan
Permanent

This Volunteer Placement is Located in:.Open to Canadian Citizens and Permanent Residents of Canada only.If you have a strong passion for vocational and technical education, digitalization initiati... Show more

IT Vendor Management Executive Leadership

SGI CANADARegina, Division No. 6, CA
Full-time

Drive strategic IT vendor success with SGI as the Vendor Management Director.Influence results through effective partnerships and governance.In this executive leadership role, you will develop and ... Show more

 • Promoted

Manager, Software Engineering (Resilience Engineering)

AffirmRegina, Canada
Full-time

Affirm is reinventing credit to make it more honest and friendly, giving consumers the flexibility to buy now and pay later without any hidden fees or compounding interest.Role OverviewWe are seeki... Show more

 • Promoted

Senior Resilience Engineering Manager At Affirm

AffirmRegina, Canada
Full-time

Shape the future of Affirm's Resilience Engineering as a Senior Manager, focused on enhancing system reliability through chaos engineering.Collaborate across teams to embed safety.We are lookin... Show more

 • Promoted

Information Systems Analyst

AutismservicesRegina, Division No. 6, CA
Full-time

We are seeking a highly skilled and innovative Information Systems Analyst to join our technical team.This role is responsible for the full lifecycle of information systems from initial client cons... Show more

 • Promoted

Remote Ciam Innovation Engineer

AffirmRegina, Canada
Remote
Full-time

Unlock your potential as a Remote CIAM Innovation Engineer, specializing in customer identity and authentication solutions.Your engineering prowess will enhance backend services that enrich account... Show more

 • Promoted

Senior Backend Architect - Remote, Scale Global Lifecycle - $150,000 - $200,000 A Year - Remote

Scale Global LifecycleRegina, Canada
Remote
Full-time

Seeking an experienced Backend Software Engineer to lead service design and development, mentor engineers, and improve engineering standards for merchant lifecycle orchestration. Show more