Vice President, Research & Development

This is a fully remote position, open to applicants in Texas.

📋 Description

• Formulate and implement the enterprise R&D and product development strategy.

• Manage portfolio governance and prioritization for new products, product transfers, reformulations, line extensions, shortage-response initiatives, and lifecycle enhancements.

• Oversee the integration and phased development of products obtained through strategic portfolio acquisitions.

• Guide the stage-gated new product development process from research and clinical fit evaluation through formulation, pilot development, validation, stability, change control, and commercial launch.

• Assess product concepts for patient and clinical needs, medication safety implications, regulatory pathways, intellectual property or commercial copy considerations, manufacturability, capacity, sourcing, quality risk, and financial feasibility.

• Offer scientific and clinical leadership for formulation development, process characterization, scale-up, analytical method readiness, component qualification, stability strategy, and technology transfer.

• Collaborate with Quality, Pharmacy Services, Technical Operations, Manufacturing, Engineering, Supply Chain, Commercial Operations, Customer Service, and Finance.

• Set portfolio and program metrics, create executive reports, resource plans, and decision-making forums.

• Ensure that development documentation is comprehensive, scientifically valid, inspection-ready, and compliant with FDA requirements, cGMP expectations, state pharmacy regulations, internal procedures, and data integrity standards.

• Provide executive oversight for product development reports, formulations, master batch records, specifications, stability protocols and reports, validation assessments, change controls, and accompanying technical documentation.

• Build, cultivate, and lead a high-performing multidisciplinary R&D team.

• Represent R&D in executive planning and discussions with customers or partners.

• Carry out additional duties as assigned.

⛳️ Requirements

• PharmD, PhD, or an advanced degree in pharmacy, pharmaceutical sciences, chemistry, chemical engineering, or a closely related scientific field.

• Over 10 years of progressive experience in pharmaceutical product development, sterile drug products, 503B outsourcing, pharmaceutical manufacturing, or a closely related regulated environment.

• More than 7 years of experience leading technical or scientific teams.

• Proven track record in guiding products from concept through formulation, scale-up, validation, stability, technology transfer, and commercial launch.

• Extensive knowledge of sterile injectable or compounded drug-product development, aseptic processing, cGMP requirements, quality systems, and risk-based decision-making.

• Experience in setting portfolio priorities, allocating resources, managing cross-functional initiatives, and communicating recommendations to executive leadership.

• Strong business and financial understanding.

• Excellent leadership, influence, communication, and change management abilities.

• Proficient in the MS Office suite.

• Must be at least 18 years of age.

• Capable of successfully passing a drug and background check.

• Must be currently authorized to work in the United States on a full-time basis; Quva cannot sponsor applicants for work visas.

🏝️ Benefits

• Extensive health and wellness benefits including medical, dental, and vision coverage.

• 401k retirement plan with company matching contributions.

• 25 days of paid time off plus 8 paid holidays each year.

• Opportunities for future career advancement.