Product Manager, Risk

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 

• Support Sales and Pre-Sales in customer discovery, demonstrations, and RFP responses as the subject matter expert for risk 

Risk Domain Knowledge — Core Requirement 

Candidates must bring practitioner-level experience with pharmaceutical risk assessment. 

• 5+ years of hands-on experience in pharmaceutical, biotech, or CDMO environments where risk assessment was a core part of the role—CMC development, process development, quality assurance, validation, or regulatory affairs 

• Direct, working familiarity with FMEA, HAZOP, and ICH Q9-aligned risk management as practiced in a GxP-regulated development or manufacturing environment 

• Understanding of how risk outputs connect to control strategy, regulatory submissions, validation planning, and post-approval lifecycle management 

• Exposure to risk practice across more than one product domain—e.g., CMC process risk and cleaning validation risk, or process risk and equipment qualification risk—is strongly preferred 

Product Management 

• 3+ years in product management or a closely adjacent role within a life sciences software company, quality systems provider, or regulated industry SaaS environment 

• Demonstrated ability to translate complex, methodology-driven workflows into clear, prioritized, buildable software requirements 

• Experience working in Agile/Scrum environments; comfortable with sprint-based delivery and iterative product development 

• Strong communication skills—able to engage credibly with bench-level scientists, QA directors, and executive stakeholders 

Education 

• B.Sc. or M.Sc. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry, or a related scientific discipline preferred 

• Equivalent industry experience considered where risk domain expertise is clearly evidenced through role scope and outcomes