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!
Job description
We are looking for a Senior OpsTrakker Project Manager to lead the end-to-end delivery of OpsTrakker digital manufacturing capabilities — including electronic equipment logbooks, electronic forms, and lightweight electronic batch record workflows — across Good Manufacturing Practice (GMP) production sites.
Based in Toronto (hybrid model), this role drives digital transformation and operational excellence by ensuring efficient deployment, compliance, and integration of OpsTrakker with Manufacturing Execution Systems (MES)
The selected candidate will manage project scope, schedule, budget, and stakeholder alignment while ensuring compliance with FDA 21 CFR Part 11 and EU GMP Annex 11.
Key Responsibilities
- Lead OpsTrakker implementation projects from discovery to hypercare, covering configuration, testing, validation, and deployment of eLogbooks, eForms, and digital workflows.
- Define and maintain the OpsTrakker roadmap aligned with global digital manufacturing initiatives and site strategy.
- Coordinate with cross-functional teams (Manufacturing, Quality, Engineering, IT, Validation) to ensure on-time, compliant delivery.
- Oversee integration activities with MES (PAS-X, Siemens Opcenter), ERP, LIMS, and other enterprise systems.
- Manage Computer System Validation (CSV), change control, release management, and audit readiness.
- Ensure full compliance with data integrity and electronic record/signature regulations (21 CFR Part 11, Annex 11).
- Promote user adoption through training, SOPs, and on-the-floor coaching; act as main contact during inspections.
- Monitor project risks, quality, and KPIs, tracking benefits such as cycle-time reduction, paper elimination, and improved documentation accuracy.
Requirements
Required Qualifications
- Bachelor’s degree or higher in Engineering, Life Sciences, Information Systems, or related field.
- 7–10 years of experience delivering digital manufacturing solutions in regulated pharmaceutical environments.
- Proven project management experience leading OpsTrakker implementations (eLogbooks and eForms).
- Strong knowledge of FDA 21 CFR Part 11, EU Annex 11, and GMP compliance for electronic systems.
- Experience integrating OpsTrakker with MES (Werum PAS-X, Siemens Opcenter) and other enterprise applications.
- Demonstrated expertise in Computer System Validation (CSV) for GMP computerized systems.
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.