Product Manager, Manufacturing & Quality (Life Sciences)

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.

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.

Assess addressable market size and required investment to determine short and long term ROI in support of the roadmap prioritization and backlog grooming activities

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.

Customers and go‑to‑market

Support sales on scoping pilots, defining success criteria and answering technical and compliance questions, and assisting with demonstrations.

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.

Veeva Vault QMS, MasterControl, TrackWise, SAP QM).

First 3 months: you know our products, clients and SDLC framework, and have run discovery with at least two client quality or manufacturing teams.

By 6 months: you own a prioritized 12-month roadmap for the manufacturing and quality line

Real ownership: your decisions shape products used in regulated manufacturing sites.

Competitive salary, benefits and versatile remote work in Montreal, and equity in a growing startup.

While GenAIz is a fully remote company, many of our core customers are located in the Montreal area.

📌 Product Manager Remote (m/f/d) (Montreal)
🏢 GenAIz
📍 Montreal