Product Manager, Manufacturing & Quality (Life Sciences)
Oct 14, 2026 · @Richard
About GenAIz
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
The role
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.
What you will do
Product strategy and discovery
- 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
Requirements and delivery
- 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.
Compliance by design
- 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.
Customers and go-to-market
- 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.
What you bring
- 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.
Nice to have
- Experience with EDC, QMS, MES or LIMS platforms (e.g. Veeva Vault QMS, MasterControl, TrackWise, SAP QM).
- Startup or small-company experience where the PM also writes, sells and supports.
- Familiarity with cloud architecture and SaaS validation approaches.
What success looks like
- 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
- By 12 months: at least three client pilots; one has converted to production use, with validation documentation the client's QA team accepted.
Why join us
- Real ownership: your decisions shape products used in regulated manufacturing sites.
- A team that treats compliance as a design input, not an afterthought.
- Direct access to leadership and clients in a company of about 20 people.
- Competitive salary, benefits and flexible remote work in Montreal, and equity in a growing startup.
To apply: send your CV and a short note on a GxP product decision you are proud of to [email protected].
GenAIz is an equal opportunity employer and welcomes applications from all qualified candidates.
