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

Remote Manager, Computer System Validation (CSV)

Alimentiv • Georgetown, Ontario
Il y a plus de 30 jours
Type de contrat
  • Temps plein
  • Télétravail
Description de poste
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.
Créer une alerte emploi pour cette recherche

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

Offres similaires

Applied Systems Engineer

L3Harris TechnologiesHamilton, ON, CA
Temps plein

Applied Systems Engineer Specialist (L3).Employees work 9 out of every 14 days – totaling 80 hours worked – and have every other Friday off.Acts as the primary technical interface between Wescam pr... Voir plus

 • Offre sponsorisée

Remote Basic Computer Skills Tutor

Varsity Tutors, a Nerdy CompanyHamilton, ON, CA
Télétravail
Temps plein

Empower students as a Remote Basic Computer Skills Tutor with Varsity Tutors.Enjoy teaching from your home while setting your own hours and earning competitive rates.In this role, you'll lead stude... Voir plus

 • Offre sponsorisée

Manager, Software Engineering (Developer Environments)

AffirmHamilton, ON, CA
Temps plein

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.Developer Productivity ex... Voir plus

 • Offre sponsorisée

Remote Ciam Innovation Engineer

AffirmHamilton, Canada
Télétravail
Temps plein

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. Voir plus

 • Offre sponsorisée

TVET Digitalization Advisor

Cuso InternationalHamilton, Ontario
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... Voir plus

 • Offre sponsorisée

Remote CIAM Innovation Engineer

Affirmhamilton, on, Canada
Télétravail
Temps plein

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... Voir plus

 • Offre sponsorisée

Quality Control Manager

Votorantim Cimentos North America (VCNA)Puslinch, Wellington County, CA
Permanent

We are Canada Building Materials (CBM), a part of Votorantim Cimentos North America (VCNA).Established principally in Ontario, Canada, St.Mary's CBM is the building materials division of St.Our CBM... Voir plus

 • Offre sponsorisée

Applications Analyst - Data Conversion

St. Joseph's Healthcare HamiltonHamilton, ON, CA
Temporaire

Applications Analyst – Data Conversion.Reporting to the Manager, Business Applications and Integrations, the Applications Analyst performs duties related to the implementation, development, and day... Voir plus

 • Offre sponsorisée

Clinic Manager

ML6 Search + Talent AdvisoryHamilton, Ontario, Canada
Temps plein

Manager, Technology Recruitment at ML6 Search + Talent Advisory.Our client is seeking a dedicated and organized Clinic Manager to lead operations at their busy healthcare clinic in Hamilton.This ro... Voir plus

 • Offre sponsorisée

Senior Specialist, System Safety

Harris Geospatial SolutionsHamilton, ON, CA
Temps plein

L3Harris is dedicated to recruiting and developing high-performing talent who are passionate about what they do.Our employees are unified in a shared dedication to our customers’ mission and quest ... Voir plus

 • Offre sponsorisée • Nouvelle offre

Basic Computer Literacy Tutor

Varsity Tutors, a Nerdy CompanyHamilton, ON, CA
Temps plein

The Varsity Tutors Live Learning Platform has thousands of students looking for online Basic Computer Literacy tutors nationally.As a tutor on the Varsity Tutors Platform, you'll have the flexibili... Voir plus

 • Offre sponsorisée

VP, Technology & Cloud Engineering

FirstOntario Credit UnionHamilton, ON, CA
Temps plein

Top-tier health and wellness benefits, including comprehensive benefits packages, a yearly health spending account and personal spending account.Enhanced mental health benefits through SunLife and ... Voir plus

 • Offre sponsorisée

Manager, Continuous Improvement

Aecon Group Inc.Hamilton, ON, CA
Temps plein

Aecon is a Canadian leader in infrastructure development, building safe, sustainable projects that benefit future generations and shape communities through transportation and energy initiatives.Aec... Voir plus

 • Offre sponsorisée

Business Systems Architect - $125,000 - $175,000 A Year - Remote

AffirmHamilton, Canada
Télétravail
Temps plein

Affirm is reinventing credit to make it more honest and friendly, giving consumers the flexibility to buy now and pay later without hidden fees or compounding interest.As a Business Systems Archite... Voir plus

 • Offre sponsorisée

Senior Manager, Ci/Cd & Release Engineering (Remote Canada) - $206,000 - $256,000 A Year - Remote

AffirmHamilton, Canada
Télétravail
Temps plein

A fintech company is seeking a Senior Manager, Software Engineering to lead CI/CD teams, driving improvements in software delivery efficiency and reliability.The ideal candidate will have over 10 y... Voir plus

 • Offre sponsorisée

Senior Software Engineering Manager Remote

AffirmHamilton, ON, CA
Télétravail
Temps plein

As a Senior Engineering Manager at Affirm, focus on amplifying developer productivity and innovation across teams.This remote role emphasizes leadership in environment management and system improve... Voir plus

 • Offre sponsorisée

Engineering Manager, MAAS — Remote + Global Travel

CanonicalHamilton, ON, CA
Télétravail
Temps plein

A leading open source software provider is seeking an Engineering Manager for the MAAS team.This role involves leading a distributed team of engineers, focusing on talent development and pushing mo... Voir plus

 • Offre sponsorisée

Manager, Technical Services

Communications & Power Industries (CPI)georgetown, on, Canada
Temps plein

CPI Power Electronics - Canada - ON - Georgetown.SHAPING THE FUTURE THROUGH INNOVATION AND DISCOVERY!.With a history spanning more than seven decades, Communications & Power Industries’ thousands o... Voir plus

 • Offre sponsorisée

Remote Engineering Manager for MAAS

CanonicalHamilton, ON, CA
Télétravail
Temps plein

Serve as the Engineering Manager for MAAS at Canonical, supporting a fully remote team throughout EMEA or the Americas.Guide the growth of private bare-metal infrastructure while mentoring your eng... Voir plus

 • Offre sponsorisée

Business System Analyst

Insight GlobalMilton, Ontario, Canada
Temps plein

Insight Global is seeking a Senior Project Analyst/BSA to join a leading bank in Downtown Toronto within their Securities division.The role requires advanced data manipulation skills to analyze lar... Voir plus