Loyal · 2 weeks ago
Senior Director, Quality Control & Analytical Development
United States
Full-time
Remote
Director/Executive
$230K/yr - $280K/yr
18+ years expLoyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. The Senior Director of Quality Control & Analytical Development will provide strategic leadership for analytical development and quality control across Loyal’s pipeline, overseeing the full QC lifecycle and ensuring regulatory compliance.
BiotechnologyPetPharmaceuticalVeterinary
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
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
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 🐶
Company equity options grant for new hires
Company
Loyal
Loyal is a clinical-stage veterinary medicine company dedicated to extending the healthy lifespan of senior dogs.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$237.14MKey Investors
age1Collaborative Fund,Valor Equity PartnersBain Capital Ventures
2026-02-11Series C· $100M
2025-02-26Series B· $22M
2024-03-21Series B· $45M
Leadership Team
Celine Halioua
Founder & CEO
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Company data provided by crunchbase