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Not Specified Permanent

Charlotte, North Carolina · USA job

Director, Digital Reference Standards Products & Partnerships (REMOTE)

US Pharmacopeia

Charlotte, North Carolina

Job description

Overview

In this role you drive the strategy, development, and adoption of USP's Digital Reference Standards products. You will own the product vision for dRS (including USP-ID) and align customer, scientific, quality, regulatory, and business needs into a clear roadmap. You will collaborate across Science, Quality, IT, Legal, Marketing, and partners to deliver validated, compliant software in a regulated life sciences environment. This position offers impact in expanding global access to high-quality medicines and shaping digital standards strategy within USP's mission. You will lead cross-functional teams, manage external partnerships, and ensure governance and stakeholder alignment while advancing

Compensation / Benefits
  • company paid time off
  • comprehensive healthcare options
  • retirement savings
  • employee wellbeing
  • professional development opportunities
  • inclusive work environment
Responsibilities
  • Structure product vision, strategy, roadmap, use cases, value proposition, success metrics, and investment recommendations for USP-ID and digital reference standards
  • Translate customer observations, validation findings, scientific limits, and regulatory expectations into testable requirements and priorities
  • Manage software development and integration roadmap with backlog prioritization, release planning, UAT, defect resolution, and documentation
  • Serve as primary PM contact for external developers, partners, distributors, and collaborators; set cadences, deliverables, and escalation paths
  • Partner with Science and Quality for validation readiness, documentation, traceability, risk assessment, remediation planning, and product claims
  • Lead customer discovery, lighthouse collaborations, demonstrations, trials, onboarding, and post-trial learning; turn needs into roadmap decisions and evidence
  • Oversee pricing, packaging, channel strategy, forecasts, budgets, contracts, licensing, and partner economics
  • Support governance through executive updates, KPI/risk reviews, and clear cross-functional ownership
  • Contribute to Digital Standards strategy and scientific framework led by the Science Division
Key requirements
  • Bachelor's degree in analytical chemistry, chemistry, chemical engineering, pharmaceutical sciences, cheminformatics, scientific computing, or a related discipline
  • Ten or more years of relevant professional experience with scientific software, digital laboratory products, analytical technologies, or regulated life science product development or customer acquisition
  • Experience identifying customer needs and product-market fit in a scientific software context
  • Experience translating customer needs into software requirements, acceptance criteria, and roadmap decisions
  • Experience managing external software development, technology, distribution, or commercialization partners
  • Experience coordinating across scientific, quality, legal, commercial, and executive stakeholders in a matrixed organization
  • Working knowledge of analytical laboratory workflows and concepts like accuracy, precision, reproducibility, robustness, traceability, and fitness for purpose
  • Structured thinking and communication; ability to explain technical risks and strategic choices to non-specialists
  • Demonstrated judgment in identifying, documenting, and escalating risks related to product, supplier, quality, architecture, and commercial aspects
  • strong stakeholder management
  • clear communication
  • structured thinking
  • scientific software product management
  • validation readiness and documentation
  • regulated environment (GxP, 21 CFR Part 11)

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