Product Manager
Role Overview
Own a segment of the AI product portfolio for pharmaceutical manufacturing and quality operations.
Work between customers, engineering and AI teams, and regulatory; contribute to client-facing materials, go-to-market, and products developed through a formal SDLC.
Location is Montreal, QC, with remote work; the role is full-time and permanent and reports to the VP of Product Management.
Key Skills for This Role
Full Job Posting
About GenAIz
GenAIz is a Montreal-based AI software company building GxP-compliant tools for pharmaceutical and life-sciences organizations.
The company combines applied AI and regulatory expertise to help clients adopt AI in validated environments.
Role details
Own a segment of the AI product portfolio for pharmaceutical manufacturing and quality operations.
Work between customers, engineering and AI teams, and regulatory; contribute to client-facing materials, go-to-market, and products developed through a formal SDLC.
Location is Montreal, QC, with remote work; the role is full-time and permanent and reports to the VP of Product Management.
Product strategy and delivery
- Develop the vision, roadmap, and prioritization for manufacturing and quality products such as quality-event triage, CAPA recommendations, and APQR/PQR generation.
- Conduct discovery with QA, manufacturing, QC, and IT/CSV teams; map workflows and find AI opportunities that do not introduce validation risk.
- Track competitors and assess market size, investment needs, and ROI to inform roadmap priorities and backlog grooming.
- Write user requirements, functional specifications, and acceptance criteria; lead backlog grooming, sprint planning, and release planning.
- Partner with engineering and data science on model behavior, human-in-the-loop design, explainability, and performance metrics.
Compliance and customer work
- Build 21 CFR Part 11, EU Annex 11, and ALCOA+ data-integrity requirements into products, including audit trails, e-signatures, access controls, and data lineage.
- Partner with regulatory on GAMP 5 categorization, risk assessments, and traceability from user requirements to test evidence.
- Plan for AI regulatory expectations, including model-update change control and FDA and EMA guidance on AI in GxP contexts.
- Support client validation, including IQ/OQ/PQ, and supplier audits with documentation and product expertise.
- Contribute to BRDs, SOWs, demos, and client presentations; support sales with pilot scope, success criteria, and technical and compliance questions.
- Turn pilot results into case studies, pricing input, and product decisions.
What you bring
- 5+ years of B2B software product management, including at least 3 years serving pharma, biotech, medical-device, or CDMO customers.
- Working knowledge of pharmaceutical manufacturing and quality processes, including deviations, CAPA, change control, batch record review, OOS/OOT, and APQR/PQR.
- Hands-on experience shipping software in GxP environments; familiarity with 21 CFR Part 11, EU Annex 11, GAMP 5, and computer system validation.
- Ability to write traceable requirements for engineering and validation teams and communicate with senior quality and manufacturing leaders.
- Bachelor’s degree in life sciences, engineering, computer science, or a related field; fluency in English. French is a strong asset.
- Experience with EDC, QMS, MES, or LIMS platforms; startup experience; and familiarity with cloud architecture or SaaS validation are nice to have.
Success measures
Within 3 months, learn the products, clients, and SDLC and conduct discovery with at least two client quality or manufacturing teams.
Within 6 months, own a prioritized 12-month roadmap for the manufacturing and quality product line.
Within 12 months, support at least three client pilots, with one converted to production use and validation documentation accepted by the client’s QA team.
Why join
- The role offers product ownership, direct access to leadership and clients, flexible remote work in Montreal, benefits, and equity.
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