Product Manager

This is a fully remote position, open to applicants in Canada.

📋 Description

• Take ownership of a segment within the AI product portfolio focused on pharmaceutical manufacturing and quality operations.

• Assist in the development and support of the product vision, roadmap, and prioritization for the manufacturing and quality product line.

• Conduct discovery sessions with QA heads, manufacturing leaders, QC labs, and IT/CSV teams at pharmaceutical, biotech, and CDMO clients.

• Analyze quality and manufacturing workflows to uncover opportunities for AI integration.

• Monitor the competitive landscape, including QMS and MES vendors that are incorporating AI features.

• Evaluate the addressable market size, necessary investment, and ROI to aid in roadmap prioritization and backlog management.

• Draft user requirements, functional specifications, and acceptance criteria for validation inputs.

• Collaborate with engineering and data science teams on model behavior, human-in-the-loop design, explainability, and performance metrics.

• Lead backlog grooming, sprint planning, and release planning efforts.

• Integrate 21 CFR Part 11, EU Annex 11, and ALCOA+ requirements into products.

• Collaborate with regulatory teams on GAMP 5 categorization, risk assessments, and traceability.

• Prepare for AI-specific regulatory expectations and model-update change control.

• Assist clients with validation (IQ/OQ/PQ) and conduct supplier audits.

• Contribute to BRDs, SOWs, demos, and client presentations.

• Support sales initiatives by scoping pilots, defining success criteria, addressing technical and compliance inquiries, and facilitating demonstrations.

• Transform pilot results into case studies, pricing insights, and product decisions.

⛳️ Requirements

• Minimum of 5 years of product management experience in B2B software.

• At least 3 years of experience serving clients in pharma, biotech, medical device, or CDMO sectors.

• Comprehensive knowledge of pharmaceutical manufacturing and quality processes, including deviations, CAPA, change control, batch record review, OOS/OOT, and APQR/PQR.

• Practical experience in delivering software solutions within GxP environments.

• Understanding of 21 CFR Part 11, EU Annex 11, GAMP 5, and computer system validation requirements.

• Proficiency in writing requirements that cater to engineers and validation teams, with a focus on traceability.

• Comfortable presenting to senior quality and manufacturing executives and drafting client-facing documents.

• Bachelor's degree in life sciences, engineering, computer science, or a related discipline.

• Proficient in English.

• Experience with EDC, QMS, MES, or LIMS platforms is advantageous.

• Experience in a startup or small company environment is a plus.

• Familiarity with cloud architecture and SaaS validation methodologies is a plus.

🏝️ Benefits

• Competitive salary.

• Comprehensive benefits package.

• Flexible remote work opportunities based in Montreal.

• Equity in a rapidly growing startup.