Product Manager

Role and company

Product strategy and discovery

• Develop vision, roadmap, and prioritization for manufacturing and quality products, including quality event triage, CAPA recommendations, and APQR/PQR generation.
• Conduct discovery with QA, manufacturing, QC, and IT/CSV teams; map workflows to identify useful AI applications without adding validation risk.
• Track QMS and MES competitors and assess market size, investment, ROI, roadmap priorities, and backlog needs.

Requirements and delivery

• Write user requirements, functional specifications, and acceptance criteria that can serve as validation inputs.
• Work with engineering and data science on model behavior, human-in-the-loop design, explainability, and performance metrics.
• Lead backlog grooming, sprint planning, and release planning.

Compliance and customer support

• Build 21 CFR Part 11, EU Annex 11, and ALCOA+ data-integrity controls into products, including audit trails, e-signatures, access control, and data lineage.
• Partner with regulatory on GAMP 5 categorization, risk assessments, traceability, AI-related regulatory expectations, and model change control.
• Support IQ/OQ/PQ client validation and supplier audits; contribute to BRDs, SOWs, demos, and client presentations.
• Support sales with pilot scoping, success criteria, technical and compliance responses, and demonstrations; use pilot results for case studies, pricing, and product decisions.

Candidate qualifications

• Requires 5+ years of B2B software product management, including 3+ years serving pharma, biotech, medical device, or CDMO customers.
• Requires knowledge of pharmaceutical manufacturing and quality processes, including deviations, CAPA, change control, batch records, OOS/OOT, and APQR/PQR.
• Requires hands-on GxP software delivery experience and familiarity with 21 CFR Part 11, EU Annex 11, GAMP 5, and computer system validation.
• Requires ability to write traceable requirements, present to senior quality and manufacturing leaders, and prepare client-facing documents.
• Requires a bachelor's degree in life sciences, engineering, computer science, or a related field, and fluency in English. French is a strong asset.

Preferred qualifications

• Experience with EDC, QMS, MES, or LIMS platforms such as Veeva Vault QMS, MasterControl, TrackWise, or SAP QM is a plus.
• Startup or small-company experience, and familiarity with cloud architecture or SaaS validation approaches, are nice to have.

Location and workplace

• The role is remote; the company is fully remote, with core customers and occasional in-person meetings or events in the Montreal area.
• Candidates located between Quebec City and Toronto are preferred.

Success milestones

Compensation

• The company describes compensation as competitive but does not state a salary amount or pay cadence.