Vice President, Research & Development

What the Vice President, R&D does each day:

• Develops and executes the enterprise R&D and product development strategy in alignment with Quva's growth, quality, supply continuity, and customer priorities
• Owns portfolio governance and prioritization for new products, acquired product transfers, reformulations, line extensions, shortage-response opportunities, and lifecycle improvements
• Leads the integration and phased development of selected products added through strategic portfolio acquisitions, including clinical, technical, regulatory, supply, validation, and launch readiness activities
• Directs Quva's stage-gated new product development process from research and clinical fit assessment through formulation, pilot development, validation, stability, change control, and commercial launch
• Ensures product concepts are evaluated for patient and clinical need, medication-safety impact, regulatory pathway, intellectual property or commercial-copy considerations, manufacturability, capacity, sourcing, quality risk, and financial viability
• Provides scientific and clinical leadership for formulation development, process characterization, scale-up, analytical method readiness, component qualification, stability strategy, and technology transfer
• Partners with Quality, Pharmacy Services, Technical Operations, Manufacturing, Engineering, Supply Chain, Commercial Operations, Customer Service, and Finance to establish clear ownership, timelines, risks, and launch criteria
• Establishes portfolio and program metrics, executive reporting, resource plans, and decision forums to improve speed, predictability, accountability, and return on development investment
• Ensures development documentation is complete, scientifically sound, inspection-ready, and compliant with applicable FDA requirements, cGMP expectations, state pharmacy requirements, internal procedures, and data-integrity standards
• Provides executive oversight for Product Development Reports, formulations, master batch records, specifications, stability protocols and reports, validation assessments, change controls, and supporting technical documentation
• Builds, develops, and leads a high-performing multidisciplinary R&D organization; clarifies roles, strengthens technical capabilities, and creates succession and development plans
• Represents R&D in executive planning and customer or partner discussions, communicates portfolio decisions and risks clearly
• Other duties as assigned

Our successful Vice President R&D has / is:

• Sense of urgency, accountability, and resourcefulness (e.g., work in changing environment)
• Self-starter, independent learner
• Communication: Promotes active listening with team members; Contributes appropriately to conversations; Strong verbal and written communication skills with the ability to work effectively with other departments within the organization and with people at all levels of the organization
• Problem Solving: Understands how various issues affect each other and the outcome of projects; Improves upon existing approaches by seeking opportunities to creatively transform
• Efficiency with MS Office suite
• Experience establishing portfolio priorities, allocating resources, managing cross-functional programs, and communicating recommendations to executive leadership
• Strong business and financial acumen with the ability to balance clinical need, supply continuity, technical feasibility, compliance, speed, and commercial value
• Exceptional leadership, influence, communication, and change-management skills in a fast-paced, multi-site environment

Minimum Requirements for this Role:

• PharmD, PhD, or advanced degree in pharmacy, pharmaceutical sciences, chemistry, chemical engineering, or a closely related scientific discipline
• 10+ years of progressive experience in pharmaceutical product development, sterile drug products, 503B outsourcing, pharmaceutical manufacturing, or a closely related regulated environment, including 7+ years leading technical or scientific teams
• Demonstrated success leading products from concept through formulation, scale-up, validation, stability, technology transfer, and commercial launch
• Deep working knowledge of sterile injectable or compounded drug-product development, aseptic processing, cGMP requirements, quality systems, and risk-based decision making
• 18+ years of age
• Able to successfully complete a drug and background check
• Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas