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Engineering Manager
Sugar Land, TX

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Quva

Vice President, Research & Development

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Job Description

Vice President, Research & Development Quva - 1.0 Sugar Land, TX Job Details 1 day ago Benefits Health insurance Dental insurance Vision insurance 401(k) matching Opportunities for advancement Qualifications Stability testing Compliance risk assessment Customer communication New product introduction engineering projects Product development project management Clinical development Pharmaceutical regulatory compliance Drug regulation GMP Chemical scale-up projects Quality risk management Pharmaceutical company experience Technology transfer (scale-up process) Leading team collaboration initiatives Sterile products production Chemical new product development projects Managing medical research teams Pharmaceutical research experience Validation design Senior leadership Pharmaceutical manufacturing facility experience Full Job 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. 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 Benefits of Working at
Quva:
Comprehensive health and wellness benefits including medical, dental and vision 401k retirement program with company match 25 paid days off plus 8 paid holidays per year National, industry-leading high growth company with future career advancement opportunities 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
About Quva:
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. Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with Quva is "at will." California Consumer Privacy Act (CCPA) Notice for Applicants and Employees (https://onequva.com/california-applicant-employee-privacy-notice-quva) Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.

Benefits

  • Paid Time Off (PTO)
  • 401(k) Plans
  • Other Retirement and Savings
  • Health Insurance