OneLIMS Validation & Deployment Lead

AMARIS GROUP SA; Toronto; On-site; CAD 110,000 - 120,000; Full time

Job summary

AMARIS GROUP SA seeks a lead consultant to drive a large-scale LIMS deployment within a regulated pharmaceutical setting. You will own pre-scoping, design validation strategy, and coordinate master data configuration in OneLIMS, guiding testing and defect closure across the validation lifecycle.

The role requires seniority to manage an entire workstream autonomously, with cross-functional collaboration for Quality, Lab Ops, and IT, while aligning business and technical stakeholders in a hybrid

Qualifications

• Extensive hands-on experience implementing enterprise LIMS solutions, preferably OneLIMS or a comparable platform.
• Experience delivering full LIMS implementation projects from scoping through deployment (not solely production support or maintenance).
• Strong background in Computer System Validation (CSV) within regulated GMP pharmaceutical environments.
• Demonstrated experience defining and leading validation strategies.
• Proven experience managing master data definition, verification, and system configuration.
• Strong testing experience throughout the validation lifecycle, including planning, execution, and defect management.
• Proven experience leading technical or cross-functional project teams, coordinating resources, assigning priorities, and driving successful project delivery.
• Demonstrated project management experience, with the ability to independently manage an entire workstream from planning through execution and reporting.
• Strong leadership skills with the confidence to challenge plans constructively, influence stakeholders, and make decisions in complex project environments.
• Excellent communication, stakeholder management, and problem-solving skills.

Responsibilities

• Lead pre-scoping workshops and translate business requirements into a clear deployment scope.
• Define and drive the Computer System Validation (CSV) strategy in compliance with GMP requirements.
• Own the definition, verification, and configuration of master data within OneLIMS.
• Plan, author, execute, and coordinate testing activities across the validation lifecycle.
• Manage defect resolution through to successful closure.
• Lead and coordinate project team members within your workstream, providing technical guidance, setting priorities, and ensuring successful delivery.
• Manage timelines, risks, dependencies, and stakeholder communication for your assigned workstream.
• Act as the primary technical point of contact for Quality, Laboratory Operations, and IT teams.
• Facilitate collaboration across cross-functional teams and drive alignment between business and technical stakeholders.
• Support deployment activities and contribute to the successful implementation of the solution.

Skills

Enterprise LIMS

CSV in GMP

Project leadership

Stakeholder management

Validation strategy

Master data management

Testing lifecycle

Cross-functional coordination

Independent workstream

Communication skills

Tools

OneLIMS

Job description

Join a large-scale laboratory digital transformation programme focused on deploying an enterprise Laboratory Information Management System (LIMS) across a regulated pharmaceutical environment.

The project is currently entering a pre-scoping phase following a programme reset. This role will play a key part in defining the deployment approach before moving into configuration, validation, testing, and implementation.

The solution supports the broader laboratory data model, extending beyond sample receiving to encompass multiple laboratory workflows.

This is a highly autonomous leadership role within a lean project team. There is no dedicated project manager overseeing individual workstreams, so each consultant is expected to independently lead their workstream from planning through delivery while also providing leadership and coordination to the team involved in its execution.

Location

Toronto, ON

Work Mode

Hybrid - 3 days per week on-site

Key Responsibilities

• Lead pre-scoping workshops and translate business requirements into a clear deployment scope.
• Define and drive the Computer System Validation (CSV) strategy in compliance with GMP requirements.
• Own the definition, verification, and configuration of master data within OneLIMS.
• Plan, author, execute, and coordinate testing activities across the validation lifecycle.
• Manage defect resolution through to successful closure.
• Lead and coordinate project team members within your workstream, providing technical guidance, setting priorities, and ensuring successful delivery.
• Manage timelines, risks, dependencies, and stakeholder communication for your assigned workstream.
• Act as the primary technical point of contact for Quality, Laboratory Operations, and IT teams.
• Facilitate collaboration across cross-functional teams and drive alignment between business and technical stakeholders.
• Support deployment activities and contribute to the successful implementation of the solution.

Required Profile

Must-Have Qualifications

• Extensive hands-on experience implementing enterprise LIMS solutions, preferably OneLIMS or a comparable platform.
• Experience delivering full LIMS implementation projects from scoping through deployment (not solely production support or maintenance).
• Strong background in Computer System Validation (CSV) within regulated GMP pharmaceutical environments.
• Demonstrated experience defining and leading validation strategies.
• Proven experience managing master data definition, verification, and system configuration.
• Strong testing experience throughout the validation lifecycle, including planning, execution, and defect management.
• Proven experience leading technical or cross-functional project teams, coordinating resources, assigning priorities, and driving successful project delivery.
• Demonstrated project management experience, with the ability to independently manage an entire workstream from planning through execution and reporting.
• Strong leadership skills with the confidence to challenge plans constructively, influence stakeholders, and make decisions in complex project environments.
• Excellent communication, stakeholder management, and problem-solving skills.

Nice-to-Have Qualifications

• Previous experience supporting programme recovery or re-scoping initiatives.
• Experience with laboratory processes beyond sample management, including:
  • Stability studies
  • Environmental monitoring
  • Quality Control (QC) laboratory workflows
• Pharmaceutical or Life Sciences consulting experience.

Expected Compensation Range:
110K. The final compensation offered will be determined based on the candidate’s level of experience, skills, and qualifications, in compliance with applicable pay transparency requirements.

Canadian Experience Requirement:
No Canadian work experience is required for this position. Candidates are encouraged to apply regardless of previous Canadian experience.

Artificial Intelligence (AI) Disclosure:
No Artificial Intelligence (AI) tools are used in the screening, assessment, or selection of candidates for this position. All stages of the recruitment process are conducted by human recruiters and hiring managers.

Statement Regarding Job Vacancy:
This position is aJob creation, created to support ongoing project needs.

Recruitment Process & Feedback Timeline:
Candidates will receive feedback on their application within a maximum of 45 days from the date of application or from their most recent interview stage.

Why choose us

• An international community bringing together more than 110 different nationalities
• An environment where trust is central: 70% of our leaders started their careers at the entry level
• A strong training system with our internal Academy and more than 250 modules available
• A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)

Amaris Consulting promotes equal opportunities. We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment. In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.