Senior Manager, Product Management – MSAT

What You'll Own

• Drive MSAT product execution. Translate product strategy and roadmap priorities into clear product requirements, epics, user stories, and specifications across eBR, Tech Transfer, and APQR.

• Bring deep domain expertise into the product. Apply your understanding of pharmaceutical manufacturing, MSAT processes, validation, data integrity, and regulatory expectations to ensure we build solutions that solve real customer problems.

• Own and prioritize the product backlog. Make day-to-day prioritization decisions, balance competing requirements, and keep delivery focused on the highest-value outcomes.

• Turn ideas into something tangible. Use AI-enabled tools to rapidly create prototypes, workflows, and mockups that help teams visualize concepts, challenge assumptions, and move from idea to execution faster.

• Be the bridge between domain and technology. Lead requirements walkthroughs and working sessions with Engineering, translating complex manufacturing, quality, and regulatory concepts into requirements technical teams can confidently build against.

• Raise the quality of AI-assisted product development. Review and refine AI-generated acceptance criteria, functional specifications, prototypes, and other product artifacts to ensure they are accurate, complete, usable, and appropriate for a regulated environment.

• Drive products through delivery. Partner with Engineering, Product Owners, Business Analysts, and SMEs throughout backlog refinement, sprint planning, reviews, testing, and release planning while surfacing risks and dependencies early.

• Support successful product launches. Partner with Sales, Product Marketing, Customer Success, and other teams to translate new capabilities into clear release communications, enablement materials, and customer-facing messaging.

• Use data to improve the product. Monitor adoption, usage, customer feedback, enhancement requests, and defect trends to identify opportunities and inform future product decisions.

What You Bring

• Bachelor’s degree in Life Sciences, Engineering, Computer Science, or a related field; an advanced degree is a plus.

• 8+ years of experience spanning MSAT, pharmaceutical manufacturing, computer system validation, quality systems, and/or regulated life sciences software within pharmaceutical, biotechnology, or medical device environments.

• 3+ years of experience in Product Management, Product Ownership, Business Analysis, or a comparable software product delivery role, ideally within enterprise SaaS.

• Hands-on understanding of MSAT workflows such as technology transfer, batch execution/eBR, process validation, continued process verification, and/or annual product quality review.

• Strong understanding of regulated computerized systems and applicable frameworks, including FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q7/Q9/Q10, ASTM E3106/E3263, and ALCOA+ data integrity principles.

• Demonstrated experience translating complex business or regulatory requirements into user stories, workflows, acceptance criteria, and functional requirements that Engineering teams can execute.

• Experience managing and prioritizing a product backlog within an Agile/Scrum software development environment.

• Practical experience using generative AI tools such as ChatGPT, Claude, or similar platforms to accelerate product discovery, requirements development, prototyping, or problem-solving.

• Strong written and verbal communication skills, with the ability to work effectively across highly technical, scientific, and commercial audiences.

Even Better If You Have

• Experience with MES, eBR, validation lifecycle management (VLMS), LIMS, eQMS, technology transfer, or other pharmaceutical manufacturing software.

• Experience with platforms such as ValGenesis, Kneat, MasterControl, TrackWise, Veeva, or comparable regulated enterprise applications.

• Previous experience working for a SaaS or enterprise software company serving pharmaceutical or biotechnology customers.

• Experience introducing AI-enabled capabilities or workflows into regulated enterprise software.

• Quality, validation, Agile, or product management certifications such as ASQ CQE/CQA, CSPO, or Pragmatic Institute.