OneLIMS Lead Jobs

Amaris Consulting

Location:
Canada, Toronto

Category:
IT - Software Development

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

We are looking for a highly skilled OneLIMS Lead for a hybrid role based in Toronto, requiring onsite presence 3 times per week. This role will drive the deployment of Labware OneLIMS for the Raw Materials phase within Quality Control laboratories as part of Sanofi’s Smart Factory and digital transformation program in Manufacturing and Supply. The OneLIMS Lead will own the functional design, deployment strategy and coordination of all activities related to Raw Materials master data, analytical methods, testing workflows, and end-user adoption across sites.

Job Responsibility:

Act as the primary interface between QC laboratories, Manufacturing & Supply, Quality, IT, and external suppliers for the OneLIMS Raw Materials scope
Lead planning and execution of the Raw Materials deployment, including scope definition, timeline, risks, interdependencies, and status reporting
Translate Raw Materials and Quality Control processes into OneLIMS configuration and workflows, ensuring harmonization across sites
Oversee master data requirements gathering, pilots, and configuration for ~600 Raw Materials records and associated analytical methods
Supervise the build and verification of LIMS calculations, limits, and business rules, ensuring regulatory compliance and data integrity
Coordinate data migration, cutover, and hypercare activities for the Raw Materials scope
Define and manage User Acceptance Testing and validation strategy in alignment with GMP, GLP, GAMP5, Annex 11, and 21 CFR Part 11
Review and approve UAT scripts, validation plans and protocols, ensuring full traceability
Ensure high-quality configuration documentation and detailed specifications
Support SOP red-lining and updates to align laboratory processes with the new system
Co-define and oversee end-user training and change management activities to ensure adoption and minimize operational disruption

Requirements:

Degree in Life Sciences, Pharmacy, Chemistry, Engineering, Information Systems, or related field
8+ years of experience in pharmaceutical or biotech environments, including 4+ years in LIMS implementation or major LIMS upgrades
Experience working in Quality Control lab operations—ideally Raw Materials testing and release
Strong knowledge of Computer System Validation in GMP/GLP context: GAMP5, Annex 11, 21 CFR Part 11
Proven experience as a functional lead, business analyst, or project manager on laboratory informatics projects, preferably multisite
Demonstrated ability to coordinate cross-functional teams and external vendors, influence decisions, and manage stakeholders
Excellent communication skills with the ability to translate between business and technical teams
Strong documentation skills and high attention to detail
Proven experience with QC or laboratory master data: materials, specs, analytical methods, limits, and static data structures
Hands-on involvement in at least one data migration or large-scale master data harmonization project including mapping, cleansing, and reconciliation
Ability to define and enforce data standards and governance in GMP/GLP environments, including change control and lifecycle management

What we offer:

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.)

Additional Information:

Job Posted:
December 06, 2025

Employment Type:

Fulltime

Work Type:

Hybrid work

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