Product Manager, Risk at Valgenesis

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: [Upgrade to PRO to see link] 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 • Support Sales and Pre-Sales in customer discovery, demonstrations, and RFP responses as the subject matter expert for risk Experience & Qualifications 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 We’re on a Mission In 2005, we disrupted the life sciences industry by introducing the world’s first digital validation lifecycle management system. ValGenesis VLMS® revolutionized compliance-based corporate validation activities and has remained the industry standard. Today, we continue to push the boundaries of innovation ― enhancing and expanding our portfolio beyond validation with an end-to-end digital transformation platform. We combine our purpose-built systems with world-class consulting services to help every facet of GxP meet evolving regulations and quality expectations. The Team You’ll Join Our customers’ success is our success. We keep the customer experience centered in our decisions, from product to marketing to sales to services to support. Life sciences companies exist to improve humanity’s quality of life, and we honor that mission.​ We work together. We communicate openly, support each other without reservation, and never hesitate to wear multiple hats to get the job done. We think big. Innovation is the heart of ValGenesis. That spirit drives product development as well as personal growth. We never stop aiming upward. We’re in it to win it. We’re on a path to becoming the number one intelligent validation platform in the market, and we won’t settle for anything less than being a market leader.​ How We Work ValGenesis is an equal-opportunity employer that makes employment decisions on the basis of merit. Our goal is to have the best-qualified people in every job. All qualified applicants will receive consideration for employment without regard to race, religion, sex, sexual orientation, gender identity, national origin, disability, or any other characteristics protected by local law.