Director, Digital Standards Strategy – Regulatory Science

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🔥 0 minutes ago

🦀 Maryland – Remote

🦀 Maryland – Remote

💵 $167.3k - $238.5k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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US Pharmacopeia

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1820

🏥 Healthcare

📦 Logistics

💼 Consulting

Healthcare • Logistics • Consulting

US Pharmacopeia is a non-profit scientific organization that develops and publishes public quality standards, reference materials, and analytical guidance for medicines, dietary supplements, and food ingredients to protect patient and consumer safety worldwide. USP provides over 7,000 reference standards, verification and audit programs, training and technical guidance (including for biologics, gene therapies, and impurities), and data-driven tools to strengthen medicine supply chains and regulatory predictability.

📋 Description

• Define the scientific framework governing USP’s Digital Standards, including scientific principles, structure, rigor requirements, and lifecycle approach. • Translate the Digital Standards framework into enterprise strategy and an operating model across USP divisions. • Oversee lifecycle governance and ensure scientific rigor consistent with traditional USP Standards. • Establish and improve cross-functional governance, including decision rights, portfolio prioritization, metrics, and escalation. • Provide executive updates, options, and recommendations to the Digital Standards steering committee and senior stakeholders. • Develop and execute regulator, government, and industry engagement strategies. • Build scientific and policy partnerships and structure pilots and collaboration agreements. • Lead external engagement with regulators, government agencies, standards bodies, scientific societies, and pharmaceutical manufacturers. • Represent USP as a thought leader through conferences, publications, and industry forums. • Oversee Digital Standards policy frameworks and translate policy into schemas, specifications, guidance, training, and playbooks. • Coordinate cross-division alignment with quality, security, legal, and commercial governance. • Oversee portfolio strategy, implementation plans, budgets, forecasts, and KPIs for the Digital Standards Business Unit. • Prioritize development of compendial Digital Standards and Digital Emerging Standards. • Build, lead, and develop a multidisciplinary team across advocacy, collaborations, scientific development, policy, and program management. • Provide functional oversight of digital products including USP-ID and MethodConnect. • Coach and develop leaders, establish performance management practices, and foster an inclusive culture. • Establish planning, portfolio review, KPI dashboard, and stakeholder communication rhythms.

🎯 Requirements

• 10+ years of progressive experience in pharmaceutical sciences, analytical chemistry, regulatory science, or a closely related scientific discipline • Demonstrated scientific credibility recognized by peers in industry, regulators, or standards bodies • 7+ years of people management experience • Experience building multidisciplinary teams across advocacy, scientific, policy, and program functions • Ability to implement change across a matrixed organization • Ability to influence senior stakeholders and shape governance, operating models, workflows, and policy frameworks • Ability to convene and align regulators, government stakeholders, standards bodies, and pharmaceutical manufacturers around a shared scientific or policy framework • Advanced degree (PhD, PharmD, MS, or equivalent) in a scientific, pharmaceutical, or analytical discipline, or comparable track record of peer-reviewed publications, public standards contributions, or recognized scientific/regulatory working-group leadership • Experience within a regulatory or standards-setting body such as FDA, EMA, or ICH • Understanding of pharmacopeial standard-setting processes and pharmaceutical product development and quality control • Experience with scientific content workflows, analytical methods, and/or digital method lifecycle frameworks • Experience with analytical chemistry technologies including NMR, FTIR, MassSpec, and HPLC • Experience establishing strategic collaborations and drafting agreements with pharmaceutical or life-science organizations • Strong strategic thinking, negotiation, communication, and stakeholder engagement skills • Comfort operating with ambiguity in a fast-evolving domain

🏖️ Benefits

• Company-paid time off • Comprehensive healthcare options • Retirement savings • Equitable access to mentorship, professional development, and leadership opportunities • Training in equitable management practices and tools • Reasonable accommodations for individuals with disabilities • Inclusive and collaborative work environment • Target Annual Bonus: % varies based on level of role