Talent.com
Alimentiv
Remote Manager, Computer System Validation (CSV)Alimentiv • Chatham-Kent, Ontario
Remote Manager, Computer System Validation (CSV)

Remote Manager, Computer System Validation (CSV)

Alimentiv • Chatham-Kent, 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) • Chatham-Kent, Ontario

Offres similaires

Customer Service - Work from Home - 50k-60k / Year

Spade RecruitingDawn-Euphemia, Ontario
Télétravail
Temps plein
Quick Apply

We’re looking for enthusiastic, self-driven, individuals to assist existing and prospective clients within our organization.This position will work with multiple clients throughout the day pr... Voir plus

 • Offre sponsorisée

CK Vets Veterinary Extern - Clinical Skills

National Veterinary AssociatesWallaceburg, ON, CA
Temps plein

Join CK Vets for a Veterinary Externship to develop your clinical abilities in Chatham-Kent, Ontario.Experience hands-on learning in a supportive, animal-focused environment.At the Chatham-Kent Vet... Voir plus

 • Offre sponsorisée

Veterinary Extern - General Practice

National Veterinary AssociatesWallaceburg, ON, CA
Temps plein

An externship experience at an NVA hospital will give students the unique opportunity to understand the day-to-day operations of the practice, and to gain valuable hands‑on clinical experience.Alth... Voir plus

 • Offre sponsorisée

Administrative Assistant Admin Work At Home - Part-Time Online Focus Group Panel

ApexFocusGroupDawn-Euphemia, Canada
Télétravail
Temps plein +2

We're now accepting participants for focus group studies! You can earn up to $750 per week working part-time from home.Simply register to see if you qualify—no experience as an administrative a... Voir plus

 • Offre sponsorisée

CUSTOMER SUPPORT CO-ORDINATOR

Parke Lane People LTDWheatley, ON, CA
Temps plein

Wheatley, Oxfordshire | Full-Time | 28-30k plus benefits.Are you a people person who thrives in a busy, fast-paced environment?.We're looking for a confident, organised, and client-focused.This is ... Voir plus

 • Offre sponsorisée

Coordinator, Project

Aecon Group Inc.Dresden, ON, CA
Temps plein

This is how Aecon Utilities is committed to delivering projects.Aecon Utilities is a leading North American utility infrastructure provider with a strong track record delivering safe, reliable and ... Voir plus

 • Offre sponsorisée

Hands-on Veterinary Externship Experience

SouthsaskatchewananimalhospitalWallaceburg, ON, CA
Temps plein

Explore veterinary medicine through a hands-on externship focused on clinical skills and community engagement.Work in a dynamic environment with experienced professionals dedicated to animal well-b... Voir plus

 • Offre sponsorisée

Earn Up To $400 Per Day By Playing Games And Taking Surveys - Up To $400 A Day - Remote

Freecash.ComDawn-Euphemia, Canada
Télétravail
Temps plein

Com is an innovative new platform for side hustle seekers who want to earn money online by playing games, taking surveys, and completing various assigned tasks.Since its launch 5 years ago, over 50... Voir plus

 • Offre sponsorisée • Nouvelle offre

Earn Extra Income - Remote

AlmediaDawn-Euphemia, Canada
Télétravail
Temps plein

Get paid for testing apps, games and surveys.Almedia runs a dynamic platform where users earn money online by completing tasks, playing games, and filling out surveys.Since our launch 5 years ago, ... Voir plus

 • Offre sponsorisée

Earn Money By Taking Surveys - Remote

AlmediaDawn-Euphemia, Canada
Télétravail
Temps plein

Get paid for testing apps, games and surveys.Almedia runs a dynamic platform where users earn money online by completing tasks, playing games, and filling out surveys.Since our launch 5 years ago, ... Voir plus

 • Offre sponsorisée

Customer Support Coordinator in Oxfordshire

Parke Lane People LTDWheatley, ON, CA
Temps plein

Become a vital part of a thriving team as a Customer Support Coordinator based near Wheatley, Oxfordshire.This role demands excellent communication and organisational skills, with a focus on client... Voir plus

 • Offre sponsorisée

Rotating Engineer

CF Industries Inccourtright, on, Canada
Temps plein

Engineering and Engineering Services.Engineering and Engineering Services.You will report to the Rotating and Reliability Supervisor within the Maintenance department.The Rotating Engineer is respo... Voir plus

 • Offre sponsorisée

Game Tester - Remote

AlmediaDawn-Euphemia, Canada
Télétravail
Temps plein

Get paid for testing apps, games and surveys.Almedia runs a dynamic platform where users earn money online by completing tasks, playing games, and filling out surveys.Since our launch 5 years ago, ... Voir plus

 • Offre sponsorisée

Veterinary Extern - General Practice

SouthsaskatchewananimalhospitalWallaceburg, ON, CA
Temps plein

An externship experience at an NVA hospital will give students the unique opportunity to understand the day‑to‑day operations of the practice, and to gain valuable hands‑on clinical experience.Alth... Voir plus

 • Offre sponsorisée

Financial Advisor - Wallaceburg, ON

ScotiabankWallaceburg, ON, CA
Temps plein

Select how often (in days) to receive an alert:.Join a purpose driven winning team, committed to results, in an inclusive and high-performing culture.At Scotiabank we help employees build their fut... Voir plus

 • Offre sponsorisée

Sales Representative - 60k / Year - Remote

Spade RecruitingDawn-Euphemia, Ontario
Télétravail
Temps plein
Quick Apply

We’re looking for enthusiastic, self-driven, individuals to assist existing and prospective clients within our organization.This position will work with multiple clients throughout the day pr... Voir plus

 • Offre sponsorisée

Community Nurse - Shift- Overnights

CarePartnersWallaceburg, ON, CA
47,38 $CA par heure
Temps partiel

Nurses working for us in community not only experience flexible scheduling and work-life balance, but they also appreciate the home care setting, where they develop meaningful therapeutic relations... Voir plus

 • Offre sponsorisée

Veterinary Extern - General Practice (Hands-On, Stipend)

National Veterinary AssociatesWallaceburg, ON, CA
Temps plein

A veterinary service provider in Wallaceburg, Ontario, offers an externship for veterinary students.This opportunity allows students to gain hands-on clinical experience in a supportive environment... Voir plus

 • Offre sponsorisée

Earn Money Testing Apps - Remote

AlmediaDawn-Euphemia, Canada
Télétravail
Temps plein

Get paid for testing apps, games and surveys.Almedia runs a dynamic platform where users earn money online by completing tasks, playing games, and filling out surveys.Since our launch 5 years ago, ... Voir plus

 • Offre sponsorisée

CUSTOMER SERVICE ADVISOR

Parke Lane People LTDWheatley, ON, CA
Temporaire

Customer Service Coordinator (Fixed-Term Contract).Wheatley, Oxfordshire | Hybrid.Are you a customer service professional who thrives in a fast-paced, detail-driven environment?.We're recruiting on... Voir plus