Role Description
The Vice President, Research & Development leads Quva Pharma’s enterprise product development strategy for ready-to-administer and compounded medications. This leader is accountable for translating hospital and health-system needs, medication shortages, portfolio opportunities, and acquired product capabilities into a prioritized, technically feasible, compliant, and commercially viable development pipeline. The role provides executive oversight from clinical and regulatory assessment through formulation, process development, analytical readiness, stability, validation, technology transfer, launch, and lifecycle improvement across Quva’s 503B manufacturing network. Ideally located in Sugar Land, Texas. If remote, will require around 50% travel.
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Develops and executes the enterprise R&D and product development strategy in alignment with Quva’s growth, quality, supply continuity, and customer priorities.
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Owns portfolio governance and prioritization for new products, acquired product transfers, reformulations, line extensions, shortage-response opportunities, and lifecycle improvements.
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Leads the integration and phased development of selected products added through strategic portfolio acquisitions, including clinical, technical, regulatory, supply, validation, and launch readiness activities.
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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.
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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.
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Provides scientific and clinical leadership for formulation development, process characterization, scale-up, analytical method readiness, component qualification, stability strategy, and technology transfer.
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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.
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Establishes portfolio and program metrics, executive reporting, resource plans, and decision forums to improve speed, predictability, accountability, and return on development investment.
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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.
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Provides executive oversight for Product Development Reports, formulations, master batch records, specifications, stability protocols and reports, validation assessments, change controls, and supporting technical documentation.
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Builds, develops, and leads a high-performing multidisciplinary R&D organization; clarifies roles, strengthens technical capabilities, and creates succession and development plans.
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Represents R&D in executive planning and customer or partner discussions, communicates portfolio decisions and risks clearly.
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Other duties as assigned.
Qualifications
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Sense of urgency, accountability, and resourcefulness (e.g., work in changing environment).
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Self-starter, independent learner.
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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.
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Problem Solving: Understands how various issues affect each other and the outcome of projects; Improves upon existing approaches by seeking opportunities to creatively transform.
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Efficiency with MS Office suite.
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Experience establishing portfolio priorities, allocating resources, managing cross-functional programs, and communicating recommendations to executive leadership.
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Strong business and financial acumen with the ability to balance clinical need, supply continuity, technical feasibility, compliance, speed, and commercial value.
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Exceptional leadership, influence, communication, and change-management skills in a fast-paced, multi-site environment.
Requirements
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PharmD, PhD, or advanced degree in pharmacy, pharmaceutical sciences, chemistry, chemical engineering, or a closely related scientific discipline.
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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.
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Demonstrated success leading products from concept through formulation, scale-up, validation, stability, technology transfer, and commercial launch.
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Deep working knowledge of sterile injectable or compounded drug-product development, aseptic processing, cGMP requirements, quality systems, and risk-based decision making.
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18+ years of age.
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Able to successfully complete a drug and background check.
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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.
Benefits
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Comprehensive health and wellness benefits including medical, dental and vision.
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401k retirement program with company match.
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25 paid days off plus 8 paid holidays per year.
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National, industry-leading high growth company with future career advancement opportunities.
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The base compensation for this role is estimated to be within the range described below. The compensation offered may vary depending on relevant factors such as experience, skills, training, education, certifications, geographic location, and market conditions.
Company Description
Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma’s multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva’s overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care.