ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle.

Learn more about working for ValGenesis, the de facto standard for paperless validation in Life Sciences: https://www.valgenesis.com/about

Responsibilities:

Risk Product Strategy & Roadmap

• Own the product vision and roadmap for risk assessment capabilities across the platform, from CMC process development through validation and continued process verification
• Define a consistent, cross-product risk framework—standardized methodologies, scoring models, governance workflows, and control strategy linkage—that can be embedded across products.
• Identify opportunities to deepen and differentiate ValGenesis’s risk capabilities based on evolving regulatory expectations, industry guidance, and customer practice
• Prioritize the roadmap through continuous discovery—customer interviews, advisory boards, site visits, and direct engagement with quality and process development teams

Risk Domain Definition & Product Design

• Define product requirements for risk assessment workflows including FMEA, HAZOP, PHA, Ishikawa, and risk ranking and filtering (RR&F)—specifying methodology logic, scoring rubrics, output formats, and regulatory traceability requirements
• Own the linkage between risk outputs and downstream product decisions: CQA/CPP criticality determinations, control strategy documentation, validation planning, and lifecycle change management
• Define how risk knowledge is captured, structured, and reused across programs, products, and sites—turning one-time assessments into institutional knowledge
• Partner with the broader Product Team to define where risk workflows should be augmented by statistical models, anomaly detection, or AI-generated insights—without owning the model layer itself
• Collaborate with UX to ensure risk tools are intuitive for practitioners: scientists, process engineers, and QA professionals who may be experts in risk methodology but not in software

Voice of the Market

• Serve as the internal authority on how risk assessment is practiced across pharmaceutical development, validation, and manufacturing—including the workflow realities, documentation burdens, and regulatory pressures that drive adoption decisions
• Engage directly with CMC scientists, validation engineers, QA managers, and regulatory affairs leads at leading pharma, biotech, and CDMO organizations
• Build and maintain relationships with key accounts and customer advisory board members whose risk maturity makes them credible product co-developers
• Represent ValGenesis at relevant industry forums: ISPE, PDA, ICH working group updates, and regulatory science conferences

Delivery & Execution

• Author product requirements—user stories, acceptance criteria, process flow documentation—that translate complex risk methodologies into buildable, testable software specifications
• Lead sprint reviews and backlog grooming with Engineering; ensure risk workflow delivery is scientifically accurate and regulatorily aligned
• Define and track adoption metrics, customer satisfaction indicators, and compliance-readiness KPIs for risk capabilities across the platform
• Manage Early Adopter Programs (EAP) for major risk capability launches, ensuring customer validation before general release

Go-to-Market & Commercialization

• Partner with Marketing and Sales Enablement to position ValGenesis risk capabilities against point solutions, legacy tools, and spreadsheet-based approaches
• Develop domain-credible messaging, battle cards, and demo narratives that resonate with practitioners and quality leadership alike