Job Description

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.



Key Responsibilities

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.

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.



Who are we?

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We're focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.



At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:

Brief Call:

Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!



Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study:

Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.



As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.

We look forward to meeting you!