Talent.com
Alimentiv
Remote Manager, Computer System Validation (CSV)Alimentiv • West Vancouver, British Columbia
Remote Manager, Computer System Validation (CSV)

Remote Manager, Computer System Validation (CSV)

Alimentiv • West Vancouver, British Columbia
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) • West Vancouver, British Columbia

Similar jobs

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

JobgetherVancouver, Metro Vancouver Regional District, 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

Engineer, PCIe Validation

TenstorrentVancouver, British Columbia, Canada
Permanent

Engineer, PCIe Validation at Tenstorrent.About the role Tenstorrent is building high-performance RISC-V CPUs and AI platforms to redefine modern computing.We are seeking an engineer to validate hig... Show more

 • Promoted

Senior Engineer Ii -Validation - $86,000 - $186,000 A Year

Microchip TechnologyPort Moody, Canada
Full-time

Seeking a System Validation Engineer to integrate, validate, and bring up advanced System-on-Chip (SoC) products.Responsibilities include developing and executing tests, building validation infrast... Show more

 • Promoted

Manager Iii, Software Development, Scot-Fulfillment Optimization, Outbound Optimization

AmazonVancouver, Canada
Full-time +1

DescriptionJoin the Fulfillment Optimization team and help drive optimization of Amazon's outbound volume for maximized flow efficiency! You will be leading systems that calibrate continuous op... Show more

 • Promoted

Design Verification Manager

RiscvVancouver, Metro Vancouver Regional District, Canada
Full-time

Vancouver, BC, Canada – Hybrid – onsite 25%-30% of the time and work from home.Senior engineer or Junior Manager – experience with team leading required.As a founding premier member of RISC-V Inter... Show more

 • Promoted

Remote-First Technical Support Manager: Lead & Elevate

commonskuVancouver, Metro Vancouver Regional District, 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

Electrical System Engineer

Artech L.L.C.richmond, metro vancouver regional district, Canada
Full-time

Lead system architecture, requirements development, and subsystem design.Develop technical specifications for AC/DC EV charging systems.Define and manage system requirements, verification plans, an... Show more

 • Promoted

Innovative CFD Staff Engineer for Remote Technical Support

SimuTech GroupVancouver, Metro Vancouver Regional District, CA
Remote
Full-time

Be a catalyst for engineering innovation as a CFD Staff Engineer.Provide expert support and training on industry-leading simulation tools in a remote work environment energized by creativity and co... Show more

 • Promoted

Senior Manager for Billing Systems Development

I did my part and supported the Regular ToiletVancouver, British Columbia, Canada
Full-time

Take charge at Asana as the Senior Engineering Manager responsible for Consumption Based Billing & Licensing in Vancouver.Embrace a hybrid work model while leading transformative engineering initia... Show more

 • Promoted

Senior Lead Clinical Data Manager - Remote Canada

Warman O'BrienVancouver, Metro Vancouver Regional District, 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

System Engineer Ii - Ftt

TransLinkVancouver, Canada
Temporary

ResponsibilitiesPrimary purpose: Provides senior level of engineering expertise to integrated system-related projects that support transportation service delivery in an integrated, multi-modal envi... Show more

 • Promoted

Survey Taker: Earn up to $25 per survey (Remote)

Earn HausSquamish, BC, CA
Remote
Full-time +1

Looking for people to participate in taking online surveys for Fortune 500 brands.All you need to do is complete online surveys by sharing your opinion.You will help influence brand decisions on se... Show more

 • Promoted

Sales Manager for Information Systems

ATIA LtdVancouver, Metro Vancouver Regional District, CA
Full-time

Shape the future of sales at ATIA Holding as a Sales Manager, specializing in information systems and applications.Your role emphasizes crafting strategies and fostering client relations.This manag... Show more

 • Promoted

System Validation Engineer (Various Levels)

Astera LabsVancouver
Full-time

System Validation Engineer (Various Levels).Astera Labs (NASDAQ: ALAB) provides rack-scale AI infrastructure through purpose-built connectivity solutions.By collaborating with hyperscalers and ecos... Show more

 • Promoted

Client Success Manager

Different Technologies Pty Ltd.Vancouver, Metro Vancouver Regional District, CA
Full-time

Are you a health or performance professional thinking about a career change? Are you passionate about how technology can help progress your profession?.If you have experience working in a clinical ... Show more

 • Promoted

Senior Systems Engineer

CytivaBurnaby, Metro Vancouver Regional District, CA
Full-time

Senior Systems Engineer – Gloveless Aseptic Filling Systems.Located in Burnaby, BC, this on‑site role reports to the Engineering Manager, Aseptic Filling.Lead system architecture and technical desi... Show more

 • Promoted

PCI Express Validation Engineer at Microchip

Microchip Technology Inc.Burnaby, Metro Vancouver Regional District, Canada
Full-time

Drive the future of technology at Microchip with a role as a PCI Express Validation Engineer.Develop, validate, and debug innovative memory controllers and switches in a supportive culture.In this ... Show more

 • Promoted

Hybrid SSD & NVMe Validation Engineer (Intermediate)

DATAmundiVancouver, Metro Vancouver Regional District, Canada
Full-time

A global data services leader is seeking an Intermediate Validation Engineer to join their Managed Services team in Vancouver.This role involves validating next-generation Non-Volatile NAND memory ... Show more

 • Promoted

Senior Manager for Billing Systems Development

AsanaVancouver
Full-time

Take charge at Asana as the Senior Engineering Manager responsible for Consumption Based Billing & Licensing in Vancouver.Embrace a hybrid work model while leading transformative engineering initia... Show more

 • Promoted

Control System Engineering Lead

Flr Federal Solutions,LLCVancouver, Canada
Full-time

Fluor is one of Canada's top employers and is recognized globally as a leader in the Engineering, Procurement, Construction, Fabrication, and Maintenance industry.Our focus on innovation and pr... Show more