Senior Director, Quality Control & Analytical Development

Loyal

22h • $230,000 - $280,000

About The Position

The Senior Director of Quality Control and Analytical Development is responsible for the strategic leadership and hands-on execution of all analytical development and QC activities across Loyal's pipeline and marketed products. This role owns the analytical and QC lifecycle from early development through commercialization, building the function, writing and reviewing key documents, and ensuring robust control strategies, regulatory compliance, and operational excellence for drug substance and drug product.

This is a deeply hands-on role. Loyal is a lean, virtual company. This person will both set the strategy and do the work, from authoring CTD analytical sections to qualifying contract testing laboratories. The immediate focus is analytical development and QC for small molecule OSD, in support of NADA resubmission and PAI readiness, while building the foundation for a commercial QC operation.

This person will build and lead a scalable AD and QC organization, establish fit-for-purpose operating models leveraging external partners, and serve as a senior CMC thought partner to the CTOO and executive leadership.

Requirements

• Ph.D., M.S., or B.S. in Analytical Chemistry, Chemistry, or a related scientific discipline; advanced degree strongly preferred
• 15+ years of progressive experience in analytical development and quality control for pharmaceutical products, with deep expertise in small molecule oral solid dosage forms
• Comfortable being both the strategist and the doer. At Loyal, this person will author CTD sections, qualify labs, and set specifications, not just oversee others doing it
• Has built and led analytical and/or QC organizations from the ground up, not just maintained inherited infrastructure
• Demonstrated experience spanning early development, clinical programs, NADA filing, commercial launch, and post-approval lifecycle management
• Proven track record authoring and reviewing analytical sections of regulatory submissions, including CTD modules, NADA/resubmission CMC sections, agency responses, and amendments
• Extensive experience with analytical method development, phase-appropriate validation, method transfer to contract testing laboratories, and GMP QC operations
• Experience qualifying and managing alternative contract testing laboratories to ensure capability and capacity redundancy
• Strong knowledge of FDA GMP regulations (21 CFR Parts 210/211) and ICH guidelines, with direct experience supporting regulatory submissions and inspections; human health experience is equally valued and CVM-specific nuances can be learned
• Has led or co-led PAI preparation from an analytical and QC perspective
• Track record of effective oversight of external GMP testing laboratories and analytical service providers, including governance, performance management, and quality issue resolution
• Comfortable operating in a lean, resource-constrained environment, builds what is needed, prioritizes well, and does not wait for perfect conditions
• Strong written communication, able to produce clear, submission-ready analytical documentation

Nice To Haves

• Experience supporting a first commercial launch and managing commercial QC testing operations
• Prior experience at a company navigating an NDA resubmission or first approval
• Veterinary or animal health industry experience; familiarity with FDA CVM and VICH guidelines
• Strong judgment in risk assessment, prioritization, and lifecycle decision-making

Responsibilities

• Set and execute the analytical development and QC strategy aligned with Loyal's CMC objectives, resubmission timeline, and PAI readiness
• Own the end-to-end analytical and QC lifecycle from early development through commercialization, including method development and validation, commercial QC readiness, product release, stability programs, and post-approval lifecycle management
• Author and review analytical sections of regulatory submissions, including CTD modules, NADA/resubmission CMC sections, responses to agency observations, and amendments; this person writes, not just reviews
• Lead cross-functional identification and lifecycle management of CQAs, specifications, and control strategies for drug substance and drug product
• Lead the development, validation, transfer, and lifecycle management of analytical methods with immediate focus on small molecule OSD, while supporting additional modalities as the pipeline evolves
• Own method transfers from development to QC and from internal to contract testing laboratories; ensure methods are robust, transfer-ready, and fit for GMP use
• Qualify, manage, and govern contract testing laboratories, including identifying and qualifying alternative testing labs to ensure capability and capacity are not single-source dependent
• Ensure contract lab reference standard oversight is governed appropriately, including qualification, traceability, and lifecycle management at external partners
• Serve as the accountable leader for GMP analytical and QC operations, ensuring inspection-ready systems and sustained regulatory compliance; own PAI readiness for all analytical and QC activities
• Establish and oversee commercial QC operations, including governance of external GMP testing laboratories and service providers
• Provide oversight of deviations, investigations, OOS/OOT events, change control, and CAPAs related to analytical and QC activities
• Serve as the senior analytical subject matter expert in interactions with FDA CVM and other global animal health regulatory agencies, including regulatory submissions, responses, and inspections
• Act as a senior CMC leader on cross-functional program teams, influencing development strategy, timelines, and investment decisions
• Build, scale, and lead a high-performing AD and QC organization, including hiring, mentoring, and developing senior technical staff
• Own and oversee analytical data systems, ensuring data integrity, 21 CFR Part 11 compliance, and robust digital infrastructure across internal and external partners
• Manage resource planning, aligning analytical and QC investments with pipeline priorities and business objectives

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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees