Product Manager

Oct 14, 2026 · @Richard

GenAIz is a Montreal-based AI software company building GxP-compliant tools for the pharmaceutical and life sciences industry. We are a team of about 20 people who combine applied AI with deep regulatory know-how, so our clients can adopt AI in validated environments without compromising compliance.

Location:

Montreal, QC (remote)
·

Reports to:

VP, Product Management
· Type:
Full-time, permanent

We are hiring a Product Manager to own a segment of our AI product portfolio for pharmaceutical manufacturing and quality operations. You will turn the daily realities of QA, QC and manufacturing teams — deviations, CAPAs, batch records, annual product quality reviews — into advanced software they can trust and validate.

You will sit between customers, our engineering and AI teams, and our regulatory function. In a company our size, you will also shape client-facing materials, influence go-to-market, and build products following a formal SDLC.

• Support and develop the vision, roadmap and prioritization for our manufacturing and quality product line (e.g. quality event triage, CAPA recommendation, APQR/PQR generation).
• Run discovery with QA heads, manufacturing leads, QC labs and IT/CSV teams at pharma, biotech and CDMO clients.
• Map end-to-end quality and manufacturing workflows to find where AI removes real effort without adding validation risk.
• Track the competitive landscape, including QMS and MES vendors adding AI features.
• Assess addressable market size and required investment to determine short and long term ROI in support of the roadmap prioritization and backlog grooming activities

• Write clear user requirements, functional specifications and acceptance criteria that hold up 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 with the engineering team.

• Build 21 CFR Part 11, EU Annex 11 and ALCOA+ data integrity requirements into products from the start (audit trails, e-signatures, access control, data lineage).
• Partner with regulatory on GAMP 5 categorization, risk assessments and traceability from user requirements to test evidence.
• Plan for AI‑specific regulatory expectations, including change control for model updates and FDA and EMA guidance on AI in GxP contexts.
• Support client validation (IQ/OQ/PQ) and supplier audits with documentation and product expertise.

• Contribute to BRDs, SOWs, demos and client presentations.
• Support sales on scoping pilots, defining success criteria and answering technical and compliance questions, and assisting with demonstrations.
• Turn pilot results into case studies, pricing input and product decisions.

• 5+ years of product management experience on B2B software, with at least 3 years serving pharma, biotech, medical device or CDMO customers.
• Working knowledge of pharmaceutical manufacturing and quality processes: deviations, CAPA, change control, batch record review, OOS/OOT, APQR/PQR.
• Hands‑on experience shipping software into GxP environments, including familiarity with 21 CFR Part 11, EU Annex 11, GAMP 5 and computer system validation.
• Ability to write requirements that serve both engineers and validation teams, with traceability in mind.
• Comfort presenting to senior quality and manufacturing leaders and writing client-facing documents.
• Bachelor's degree in life sciences, engineering, computer science or a related field.
• Fluency in English;
  French is a strong asset.

• Experience with EDC,…