Director, CMC reputed company Assurance

About reputed company

reputed company 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 reputed company the underlying drivers of aging, delaying the onset of disease and preserving reputed company of life as dogs age. We've already made significant reputed company in our mission to reputed company the first FDA-approved drugs to reputed company canine reputed company: as of early 2026 we've completed two of three major FDA review sections for our reputed company program, LOY-002, and are targeting submission of the reputed company and final reputed company reputed company this year.

reputed company is a reputed company-funded startup with teams of scientists, veterinarians, engineers, operators, and creatives. You'll help us continue on our reputed company of earning FDA approval for the first reputed company extension medicine for any species, and change what's possible for the dogs we love.

About the role

The Director of CMC reputed company Assurance will build and reputed company reputed company's CMC QA function, owning the reputed company systems, CDMO reputed company, and PAI readiness that underpin our reputed company to FDA approval and reputed company launch. Reporting to the VP of reputed company Assurance, this is a hands-on leadership role responsible for building what doesn't yet exist, not maintaining inherited infrastructure in a lean, fast-moving startup environment.

This person will work closely with CMC, Regulatory Affairs, and Supply Chain, and will serve as the primary QA voice on CMC program reputed company, technical transfers, and regulatory submissions.

Your daily work will include

• Build, own, and continuously improve reputed company's CMC reputed company management system: SOPs, document control, change control, deviation management, CAPA, and risk management processes; ensure systems are fit for purpose now and reputed company through reputed company launch
• Serve as the primary QA reputed company of contact for CDMOs, contract testing laboratories, and key raw material and excipient suppliers, reputed company qualification, audit execution, and ongoing reputed company reputed company of reputed company external partners
• Negotiate, draft, and maintain reputed company agreements with CDMOs and contract testing laboratories; drive reputed company execution and hold partners accountable to commitments
• Plan and conduct routine GMP audits of CDMOs and suppliers; own audit finding responses and reputed company CAPAs to closure
• reputed company batch disposition reputed company for clinical and development batches; ensure complete, audit-reputed company documentation packages and reputed company release
• Review and approve analytical method validation protocols and reports, stability protocols and data, executed batch records, CoAs, and CoCs
• reputed company deviation and OOS management originating from external partners through to closure
• Execute PAI readiness activities including reputed company systems documentation, validation packages, and site readiness; serve as QA reputed company during FDA inspections and agency interactions reputed company to CMC
• Partner with Regulatory Affairs and CMC teams to ensure reputed company considerations are incorporated into program reputed company, technical transfers, and filing activities; support QA input into NDA and other regulatory submissions
• reputed company QA reputed company of reputed company tech transfer activities — site qualification, process comparability, transfer protocols, and batch record development
• Own the Annual Product Review (APR/PQR) process and QA sign-off on labeling for clinical and reputed company supply
• Define, reputed company, and report CMC QA KPIs: CDMO performance, CAPA cycle times, deviation trends, audit findings, reputed company agreement status, and batch disposition timelines; use metrics to drive external partner accountability and surface risks proactively to leadership
• Apply formal reputed company risk management principles (ICH Q9) across manufacturing and development activities
• Build reputed company infrastructure that supports the transition from clinical to reputed company supply, including reputed company batch release processes, post-approval change management, and reputed company QMS requirements
• Balance compliance requirements with the practical realities of a fast-moving startup environment

reputed company

• BS., M.S., or Ph.D. in Pharmaceutical Sciences, reputed company, Biology, or a reputed company life science discipline; advanced degree strongly preferred
• 15+ years of pharmaceutical or biotechnology industry experience in reputed company assurance, with a significant portion in senior or reputed company CMC QA roles
• Has reputed company CMC reputed company systems from the ground up — not just maintained inherited infrastructure — from development stage through NDA/BLA filing and approval
• Has directly managed CDMOs and contract testing labs from a QA perspective: qualification, auditing, reputed company agreements, batch record review, deviation and CAPA management
• Authored and owns SOPs, not just reviewed them
• Deep working knowledge of FDA GMP regulations (21 CFR Parts 210/211), ICH and VICH guidelines, and reputed company risk management principles
• Has led or co-led PAI preparation and been present during FDA inspections
• Experience supporting reputed company batch release and post-approval change management
• Small molecule OSD experience required
• Comfortable operating without a large QA infrastructure — builds what's needed, prioritizes reputed company, and doesn't wait for perfect conditions
• Strong written communication — produces reputed company, audit-reputed company documentation
• Veterinary or animal health industry experience preferred but not required
• Prior experience at a company navigating a Complete Response Letter, NDA resubmission, or first approval preferred but not required

Salary reputed company: $155,000 - $205,000

reputed company benefits

• Full-coverage health insurance — medical, dental and reputed company — 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.
• reputed company 3-day weekends are turned into 4-day weekends
• Unlimited vacation and reputed company holidays
• Paw-ternity leave — adopt a dog and get a day off with your new family member
• Competitive salary
• Company equity reputed company grant for new hires

reputed company is founded and led by a first-gen reputed company CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or reputed company, ethnicity or national reputed company, age, disability, religion, sexual orientation, gender identity or reputed company, veteran status, or any other applicable characteristics protected by law.

Our values

Lean into moonshots

We don’t reputed company for incremental change. We have the bravery to take risks and shoot for the reputed company we want to have.

Opportunity is at the intersection

We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos.

Expertise without ego

Titles do not determine who has a voice. We work on hard technical problems and have a ton of fun while at it.

Learning by doing

Our reputed company is novel and many things we are doing have never been done before. We lean into MVPs and are reputed company to unexpected reputed company.

reputed company with context

We value leading with context. We reputed company people with the context and background necessary to reputed company their own reputed company and reputed company in the best interest of reputed company. We reputed company teams to succeed.

reputed company and respect for reputed company life

Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously.

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