Responsibilities:
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
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
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
Partner with Marketing and Sales Enablement on product launches, competitive positioning, and solution messaging
Develop narratives grounded in manufacturing and regulatory credibility
Product Strategy & Roadmap
Voice of the Market
Delivery & Execution
Go-to-Market & Commercialization
Requirements:
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
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
B.Sc., M.Sc., 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
Manufacturing Execution Domain Knowledge
Product Management
Education
Skills Required
- 5+ years in pharmaceutical, biotech, or CDMO manufacturing operations
- Direct experience with electronic batch records and deviation management
- 3+ years in product management within life sciences software or SaaS
- B.Sc. in Chemical Engineering, Pharmaceutical Sciences, Industrial Engineering, Computer Science, or related
What We Do
ValGenesis delivers integrated and smart solutions that support the digital transformation of the life sciences industry. With a portfolio that covers the whole product lifecycle, ValGenesis has a digital or technical solution that brings value to each step of your validation and manufacturing processes and their related activities.


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