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Senior Director, Quality Control & Analytical Development

Loyal · Remote
RemoteFull-timeCMC Technical OperationsHealthcare$128,000–$173,000/yr
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About the Senior Director Quality Control Analytical Development role

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About Loyal Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. Our mission is to help dogs live longer, healthier lives. We're pioneering a new category of veterinary prescription drugs that proactively and preventatively target the underlying drivers of aging, delaying the onset of disease and preserving quality of life as dogs age. We've already made significant progress in our mission to develop the first FDA-approved drugs to extend canine lifespan: as of early 2026 we've completed two of three major FDA review sections for our lead program, LOY-002, and are targeting submission of the third and final section later this year. Loyal is a well-funded startup with teams of scientists, veterinarians, engineers, operators, and creatives. You'll help us continue on our path of earning FDA approval for the first lifespan extension medicine for any species, and change what's possible for the dogs we love. About the role The Senior Director of Quality Control & Analytical Development will be providing strategic leadership for all analytical development and commercial quality control across Loyal’s pipeline and marketed products. You will oversee the full QC lifecycle from early development through commercialization, ensuring robust control strategies, regulatory compliance, and operational excellence. Builds and scales the QC/AD organization, leveraging internal and external partners, with deep expertise in OSD analytics and animal health regulatory requirements. Your daily work will include 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. About you 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 managemen…

Salary estimate

$128,000 – $173,000/yr
Provided by the employer.

Skills for this role

Leadership

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About Loyal

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