Actively Hiring
GE
Product Manager
GenAIz
Montréal
Skills:
SAP QM
Job Description
Job Title: Product Manager
Company: GenAIz
Job Category: SAP QM
Roles & Responsibilities:
Product Manager, Manufacturing \& Quality (Life Sciences)
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.
What you will do
* 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
* 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.
Work Location: Montréal, QC, Canada
Availability: Full time
Requirements
Requirements and delivery
* 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.
* 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.
* 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.
Key Skills: SAP QM
Salary: CAD 120000 - 120000 per yearly