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

Remote Manager, Computer System Validation (CSV)

Alimentiv • Greater Sudbury, 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) • Greater Sudbury, Ontario

Similar jobs

Computer programming Private Tutoring Jobs Blezard Valley

SuperprofBlezard Valley, Canada
CA$20.00 hourly
Full-time +1

Superprof is Canada's #1 tutoring platform, and we're actively recruiting passionate tutors! Whether you're a student, a professional, or simply someone who loves teaching, join the largest communi... Show more

 • Promoted

Computer programming Private Tutoring Jobs Capreol

SuperprofCapreol, Canada
CA$20.00 hourly
Full-time +1

Superprof is Canada's #1 tutoring platform, and we're actively recruiting passionate tutors! Whether you're a student, a professional, or simply someone who loves teaching, join the largest communi... Show more

 • Promoted

Algebra Private Tutoring Jobs Blezard Valley

SuperprofBlezard Valley, Canada
CA$20.00 hourly
Full-time +1

Superprof is Canada's #1 tutoring platform, and we're actively recruiting passionate tutors! Whether you're a student, a professional, or simply someone who loves teaching, join the largest communi... Show more

 • Promoted

Geometry Private Tutoring Jobs Capreol

SuperprofCapreol, Canada
CA$20.00 hourly
Full-time +1

Superprof is Canada's #1 tutoring platform, and we're actively recruiting passionate tutors! Whether you're a student, a professional, or simply someone who loves teaching, join the largest communi... Show more

 • Promoted

Operational Leader at Tim Hortons

Ontario Trillium FoundationGarson, ON, CA
Full-time

Become a force for operational success at Tim Hortons as a Restaurant Supervisor in Garson, ON.Your leadership will enhance guest experiences and team engagement every day.As an Operational Leader,... Show more

 • Promoted

Information Technology Private Tutoring Jobs Capreol

SuperprofCapreol, Canada
CA$20.00 hourly
Full-time +1

Superprof is Canada's #1 tutoring platform, and we're actively recruiting passionate tutors! Whether you're a student, a professional, or simply someone who loves teaching, join the largest communi... Show more

 • Promoted

Algebra Private Tutoring Jobs Capreol

SuperprofCapreol, Canada
CA$20.00 hourly
Full-time +1

Superprof is Canada's #1 tutoring platform, and we're actively recruiting passionate tutors! Whether you're a student, a professional, or simply someone who loves teaching, join the largest communi... Show more

 • Promoted

Biology Private Tutoring Jobs Blezard Valley

SuperprofBlezard Valley, Ontario (ON), CA
Full-time

Superprof is Canada's tutoring platform, and we're actively recruiting passionate tutors! Whether you're a student, a professional, or simply someone who loves teaching, join the largest community ... Show more

 • Promoted

Biology Private Tutoring Jobs Capreol

SuperprofCapreol, Ontario (ON), CA
Full-time

Superprof is Canada's tutoring platform, and we're actively recruiting passionate tutors! Whether you're a student, a professional, or simply someone who loves teaching, join the largest community ... Show more

 • Promoted

Restaurant Supervisor

Ontario Trillium FoundationGarson, ON, CA
Full-time

Falconbridge Highway, Garson, ON, P3L 1J6.As a Restaurant Supervisor you empower and lead your team to deliver exceptional guest experiences.You promote a respectful team environment and manage tea... Show more

 • Promoted

Information Technology Private Tutoring Jobs Blezard Valley

SuperprofBlezard Valley, Canada
CA$20.00 hourly
Full-time +1

Superprof is Canada's #1 tutoring platform, and we're actively recruiting passionate tutors! Whether you're a student, a professional, or simply someone who loves teaching, join the largest communi... Show more

 • Promoted

Physics Private Tutoring Jobs Blezard Valley

SuperprofBlezard Valley, Canada
CA$20.00 hourly
Full-time +1

Superprof is Canada's #1 tutoring platform, and we're actively recruiting passionate tutors! Whether you're a student, a professional, or simply someone who loves teaching, join the largest communi... Show more

 • Promoted

Geometry Private Tutoring Jobs Blezard Valley

SuperprofBlezard Valley, Canada
CA$20.00 hourly
Full-time +1

Superprof is Canada's #1 tutoring platform, and we're actively recruiting passionate tutors! Whether you're a student, a professional, or simply someone who loves teaching, join the largest communi... Show more

 • Promoted

Trigonometry Private Tutoring Jobs Blezard Valley

SuperprofBlezard Valley, Canada
CA$20.00 hourly
Full-time +1

Superprof is Canada's #1 tutoring platform, and we're actively recruiting passionate tutors! Whether you're a student, a professional, or simply someone who loves teaching, join the largest communi... Show more

 • Promoted

Case Manager - RN

HinesConiston, ON, CA
Full-time

Hines is a nationwide, independent leader in personalized managed health care, focused on what’s important to you—comprehensive services with the program excellence and cost containment that you de... Show more

 • Promoted

System Integrator

CIMAGreater Sudbury, Sudbury District, CA
Permanent

Sector Name: Operational & Digital Technologies.Compensation: CAD 67,440 - CAD 92,730 - yearly.Welcome to a place where people are at the heart of everything we do.Welcome to people with an inspiri... Show more

 • Promoted

Physics Private Tutoring Jobs Capreol

SuperprofCapreol, Canada
CA$20.00 hourly
Full-time +1

Superprof is Canada's #1 tutoring platform, and we're actively recruiting passionate tutors! Whether you're a student, a professional, or simply someone who loves teaching, join the largest communi... Show more

 • Promoted

Trigonometry Private Tutoring Jobs Capreol

SuperprofCapreol, Canada
CA$20.00 hourly
Full-time +1

Superprof is Canada's #1 tutoring platform, and we're actively recruiting passionate tutors! Whether you're a student, a professional, or simply someone who loves teaching, join the largest communi... Show more

 • Promoted

TVET Digitalization Advisor

Cuso InternationalGreater Sudbury, 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... Show more

Supervisor

Ontario Trillium FoundationGarson, ON, CA
Full-time

Falconbridge Highway, Garson, ON, P3L 1J6.As a Restaurant Supervisor you empower and lead your team to deliver exceptional guest experiences.You promote a respectful team environment and manage tea... Show more