Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowFirst seen 35 hours ago

Lead, Computerized Systems Validation - Canada

innovaderm/15.003101 open roles

Where
Canada (remote), Remote
Work mode
Remote
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowLead, Computerized Systems Validation - Canadainnovaderm/15.003 · Canada (remote), Remote

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on innovaderm/15.003's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

11.5% of postings close within 7 days. Measured by our own scanner across the market. innovaderm/15.003 postings stay open a median of 1 days.

Share of postings closed within
  1. 2.0%1 day
  2. 4.3%3 days
  3. 11.5%7 days
  4. 18.1%14 days
  5. 35.6%30 days
  6. 44.6%60 days
This job: first seen 35 hours ago

innovaderm/15.003 median: 1 days open

The posting

The CSV Lead is a senior individual contributor and subject matter expert responsible for leading complex, high-risk computerized system validation initiatives across the system lifecycle. Working in close collaboration with the Associate Director, Computerized Systems Validation, the CSV Lead provides technical expertise for validation strategy, planning, execution, and reporting; ensures the quality and completeness of validation deliverables; and promotes consistent application of risk-based, data-integrity, and GxP requirements. The role partners with system owners, operations, IT, Quality, and vendors. The position does not carry routine people-management accountability but may coordinate project teams and provide functional direction.

Requirements

More specifically, the CSV Lead:

  • Leads validation workstreams for new GxP computerized systems, upgrades, and system retirements, coordinating activities and deliverables with system owners, business functions, IT, Quality, and vendors.
  • Facilitates project initiation and risk-assessment discussions to determine GxP impact, system criticality, validation scope, applicable controls, supplier leverage, and the risk-based validation strategy.
  • Develops, reviews, and/or approves by applicable procedures, validation deliverables including validation plans, user requirements specifications, system risk assessments, functional and configuration specifications, test scripts, data migration verification, traceability matrices, deviation records, and validation summary reports.
  • Provides technical oversight of validation execution, ensures objective evidence is complete and attributable, and drives the timely resolution of test defects, discrepancies, and documentation gaps before release or closure.
  • Performs peer reviews of validation packages and takes accountability for ensuring assigned packages are complete, internally consistent, traceable, inspection-ready, and compliant with applicable policies, SOPs, regulations, and industry practices.
  • Assesses vendor validation documentation to determine the extent to which supplier evidence may be leveraged and supports vendor qualification or audit activities when required.
  • Leads or provides CSV oversight for lifecycle controls, including change control, periodic review, access and security considerations, backup and restoration, data migration, archival, business continuity, CAPA, and system retirement.
  • Acts as team support for complex validation or validation strategy, data integrity, electronic records and signatures, cloud/SaaS, interfaces, emerging technology, and other computerized-system issues.
  • Builds effective relationships with system owners and system administrators and provides guidance on their responsibilities for maintaining the validated state of GxP computerized systems.
  • Coordinates project-level CSV schedules, dependencies, priorities, risks, and status reporting; identifies resource or timeline constraints and escalates material risks to the Manager, CSV in a timely manner.
  • Mentors CSV Analysts and provide day-to-day technical direction and review feedback, shares current industry practices, and supports consistent execution across the CSV team.
  • Develops and delivers CSV training for project teams (system owners, business SMEs, testers) as required by projects or process changes.
  • Contribute to the creation and revision of CSV policies, SOPs, templates, tools, metrics, and process-improvement initiatives, and supports implementation of approved changes.
  • Maintains current knowledge of applicable computerized-system regulations, guidance, industry standards, and evolving technologies, including cloud services, connected devices, automation, and artificial intelligence, and recommends appropriate updates to CSV practices.
  • Supports internal audits, vendor audits, client audits and requests for information, and regulatory inspections by preparing evidence, responding to questions, and supporting remediation activities.

Our company

At Indero, formely Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

As a CSV Lead, you will be eligible for the following perks:

  • Permanent full-time position
  • Flexible schedule
  • Home-based position
  • Ongoing learning and development

Work location

The successful candidate for this position is given to work remotely on the Eastern part of North America.

About Indero, formely Innovaderm

Indero, formely Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero, formely Innovaderm continues to grow and expand in North America and Europe.

Indero, formely Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero, formely Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero, formely Innovaderm only accepts applicants who can legally work in Canada

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against innovaderm/15.003's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on innovaderm/15.003's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    innovaderm/15.003's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.