Product Manager, Manufacturing Execution & Batch Lifecycle

**About 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: .[](http://valgenesis.com/about) **About the Role:** ### Responsibilities: **Product Strategy & Roadmap** - Own and evolve the product roadmap for Electronic Batch Records (EBR) and adjacent batch execution workflows, grounded in customer discovery, regulatory intelligence, and competitive market analysis - Prioritize platform capabilities through structured discovery—customer interviews and feedback, EAP programs, and on-site manufacturing observations - Translate evolving FDA CSA, EU Annex 11, 21 CFR Part 11, ALCOA++, and ICH Q10 expectations into actionable roadmap input - Partner with other Product Managers to ensure coherent positioning and continutiy across the platform **Voice of the Market** - Serve as an internal authority on batch execution, review-by-exception, and deviation workflows across pharma, biotech, and CDMO segments - Support Sales and Pre-Sales in customer discovery, product demonstrations, and competitive evaluations against incumbents **Delivery & Execution** - Author product requirements—solution definition, mock-ups creation, use-case documentation—that translate batch manufacturing workflows into buildable software specifications - Manage Early Adopter Program (EAP) and early release cycles - Partner to define governed-AI use cases **Go-to-Market & Commercialization** - Partner with Marketing and Sales Enablement on product launches, competitive positioning, and solution messaging - Develop narratives grounded in manufacturing and regulatory credibility ### Requirements: **Manufacturing Execution Domain Knowledge** - 5+ years of hands-on experience in pharmaceutical, biotech, or CDMO manufacturing operations—batch execution, manufacturing sciences (MSAT), site QA, manufacturing IT, or technical operations - Direct, working familiarity with electronic batch records, review-by-exception, deviation management, and batch release workflows in a regulated environment - Working knowledge of MES/eBR platforms and the manufacturing data substrate - Familiarity with MES, LIMS, ERP, QMS, eLogbooks, and GxP-regulated informatics - Working knowledge of GxP regulatory frameworks: 21 CFR Part 11, EU Annex 11, ALCOA++, FDA CSA, and ICH Q10 **Product Management** - 3+ years in product management or a closely adjacent role within a life sciences software, MES, or industrial SaaS company - Proven ability to translate complex manufacturing and quality workflows into clear, prioritized software requirements - Strong communication skills—credible with floor operators, site QA leaders, and C-suite executives alike - Experience with Agile/Scrum delivery nice to have **Education** - ., ., or Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Industrial Engineering, Computer Science, or a related discipline - Equivalent experience considered where manufacturing execution domain expertise is clearly evidenced