VP, Quality Control & Analytical Development jobs in United States
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Loyal · 6 hours ago

VP, Quality Control & Analytical Development

Loyal is a clinical-stage veterinary medicine company focused on developing drugs to enhance the lifespan and health of dogs. The VP of Quality Control & Analytical Development will lead the analytical development and quality control activities for Loyal's products, ensuring regulatory compliance and operational excellence throughout the product lifecycle.

BiotechnologyPetVeterinary
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Comp. & Benefits

Responsibilities

Set and execute the global analytical development and quality control strategy aligned with Loyal’s corporate and CMC objectives
Own the end-to-end analytical and QC lifecycle from early development through commercialization, including commercial QC readiness, product release, stability programs, and post-approval lifecycle management
Serve as the accountable executive for GMP analytical and QC operations, ensuring inspection-ready systems and sustained regulatory compliance
Act as a senior CMC leader on cross-functional program teams, influencing development strategy, timelines, and investment decisions
Lead the development, validation, transfer, and lifecycle management of analytical methods and control strategies, with immediate focus on small-molecule oral solid dosage products, while supporting additional modalities as the pipeline evolves
Lead cross-functional identification and lifecycle management of CQAs, specifications, and control strategies
Establish and oversee commercial QC operations, including governance of external GMP testing laboratories and service providers
Provide executive oversight of deviations, investigations, OOS/OOT events, and CAPAs related to analytical and QC activities
Serve as a senior analytical subject-matter expert in interactions with FDA Center for Veterinary Medicine (CVM) and other global animal health regulatory agencies, including regulatory submissions, responses, and inspections
Select, manage, and govern external analytical laboratories, CDMOs (as applicable), and other partners to ensure technical performance, compliance, and cost effectiveness
Build, scale, and lead a high-performing QC and analytical development organization, including hiring, mentoring, and developing senior technical leaders
Establish operating models that balance internal capabilities with strategic outsourcing to support a growing and commercial portfolio
Manage resource planning, aligning analytical and QC investments with pipeline priorities and long-term business objectives

Qualification

Analytical ChemistryQuality ControlRegulatory ComplianceSmall-Molecule OSD ExpertiseGMP OperationsAnalytical Method DevelopmentAnimal Health RegulationsLeadership SkillsCommunication SkillsStrategic Mindset

Required

Ph.D., M.S., or B.S. in Analytical Chemistry, Chemistry, or a related scientific discipline
18+ years of progressive experience in analytical development and quality control for pharmaceutical products, with deep expertise in small-molecule oral solid dosage forms
Demonstrated experience spanning early development, clinical programs, commercial launch, and post-approval lifecycle management
Proven success building and leading analytical and/or QC organizations, including hiring, mentoring, and developing senior technical leaders
Extensive experience with analytical method development, phase-appropriate validation, method transfer, and GMP QC operations
Strong knowledge of animal health regulatory requirements, including FDA CVM and relevant global guidelines (e.g., VICH; ICH as applicable), with direct experience supporting regulatory submissions and inspections
Track record of effective oversight of external GMP testing laboratories and analytical service providers, including governance, performance management, and quality issue resolution
Strategic mindset with the ability to translate scientific and regulatory complexity into clear, actionable business recommendations
Comfortable operating in a fast-paced, growth-stage environment, balancing hands-on technical leadership with executive-level decision-making
Excellent communication and influencing skills, with the ability to engage credibly with executive leadership, regulators, and external partners

Preferred

Prior VP- or executive-level leadership experience in CMC, Analytical Development, or Quality Control
Experience supporting first-time commercial launches
Strong judgment in risk assessment, prioritization, and lifecycle decision-making

Benefits

Full-coverage health insurance — medical, dental and vision — for you and your dependents
$1,000 home office equipment stipend
$1,200/year learning budget for books, courses, etc.
$250/month wellness budget for gym, cleaners, spa, food, etc.
All 3-day weekends are turned into 4-day weekends 🎉
Unlimited vacation and paid holidays
Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶
Competitive salary
Company equity options grant for new hires

Company

Loyal

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Loyal is a biotechnology company developing medicines to extend dogs lifespan and maintain their quality of life.

Funding

Current Stage
Growth Stage
Total Funding
$137.07M
Key Investors
Bain Capital VenturesBridge BankKhosla Ventures
2025-02-26Series B· $22M
2024-03-21Series B· $45M
2024-03-21Debt Financing· $12M

Leadership Team

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Celine Halioua
Founder & CEO
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Sudharika Gogna
Chief Operating Officer
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Company data provided by crunchbase