Product Manager

Job not on LinkedIn

đź•’ 4 days ago

🇨🇦 Canada – Remote

đź’µ $120k / year

⏰ Full Time

🟡 Mid-level

đźź  Senior

âś… Product Manager

đź‘» Ghost score 24%

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Logo of GENAIZ

GENAIZ

11 - 50 employees

Founded 2016

🏥 Healthcare

đź’Ľ Consulting

📦 Logistics

đź’° Seed on 2018-02

Healthcare • Consulting • Logistics

<GENAIZ> is an AI-driven intelligent automation platform for life sciences and healthcare organizations that harmonizes diverse data sources and connects systems to accelerate product development, regulatory review, and compliance workflows. Its GxP-compliant, enterprise-grade solutions—offered as single-tenant cloud or on-premises deployments—include plug-and-play tools like RiskRelief. AI, ConformityCheck. AI, FileSub. AI, DueDil. AI, and LitReview. AI to automate data cleaning, anomaly detection, due diligence, and literature review at scale. GENAIZ focuses on secure data ownership, ethics, and high-throughput processing to help pharmaceutical and biotech teams make faster, more reliable decisions.

đź“‹ Description

• Own a segment of the AI product portfolio for pharmaceutical manufacturing and quality operations • Support and develop product vision, roadmap and prioritization for the manufacturing and quality product line • Run discovery with QA heads, manufacturing leads, QC labs and IT/CSV teams at pharma, biotech and CDMO clients • Map quality and manufacturing workflows to identify opportunities for AI • Track the competitive landscape, including QMS and MES vendors adding AI features • Assess addressable market size, required investment and ROI to support roadmap prioritization and backlog grooming • Write user requirements, functional specifications and acceptance criteria for validation inputs • Collaborate 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 • Build 21 CFR Part 11, EU Annex 11 and ALCOA+ requirements into products • Partner with regulatory on GAMP 5 categorization, risk assessments and traceability • Plan for AI-specific regulatory expectations and model-update change control • Support client validation (IQ/OQ/PQ) and supplier audits • Contribute to BRDs, SOWs, demos and client presentations • Support sales with pilot scoping, success criteria, technical and compliance questions, and demonstrations • Turn pilot results into case studies, pricing input and product decisions

🎯 Requirements

• 5+ years of product management experience on B2B software • 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 into GxP environments • Familiarity with 21 CFR Part 11, EU Annex 11, GAMP 5 and computer system validation • Ability to write requirements serving 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 • Experience with EDC, QMS, MES or LIMS platforms is a plus • Startup or small-company experience is a plus • Familiarity with cloud architecture and SaaS validation approaches is a plus

🏖️ Benefits

• Competitive salary • Benefits • Flexible remote work in Montreal • Equity in a growing startup

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