Healthcare's Leading End-to-End Digital Health Platform
Director, CMC Quality Assurance
Location
United States
Posted
43 days ago
Salary
$155K - $205K / year
Seniority
Lead
Job Description
Director, CMC Quality Assurance
Loyal
• Build, own, and continuously improve Loyal's CMC quality management system: SOPs, document control, change control, deviation management, CAPA, and risk management processes; ensure systems are fit for purpose now and scalable through commercial launch • Serve as the primary QA point of contact for CDMOs, contract testing laboratories, and key raw material and excipient suppliers, lead qualification, audit execution, and ongoing quality oversight of all external partners • Negotiate, draft, and maintain quality agreements with CDMOs and contract testing laboratories; drive timely execution and hold partners accountable to commitments • Plan and conduct routine GMP audits of CDMOs and suppliers; own audit finding responses and track CAPAs to closure • Lead batch disposition decisions for clinical and development batches; ensure complete, audit-ready documentation packages and timely release • Review and approve analytical method validation protocols and reports, stability protocols and data, executed batch records, CoAs, and CoCs • Oversee deviation and OOS management originating from external partners through to closure • Execute PAI readiness activities including quality systems documentation, validation packages, and site readiness; serve as QA lead during FDA inspections and agency interactions related to CMC • Partner with Regulatory Affairs and CMC teams to ensure quality considerations are incorporated into program decisions, technical transfers, and filing activities; support QA input into NDA and other regulatory submissions • Provide QA oversight of all 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 commercial supply • Define, track, and report CMC QA KPIs: CDMO performance, CAPA cycle times, deviation trends, audit findings, quality agreement status, and batch disposition timelines; use metrics to drive external partner accountability and surface risks proactively to leadership • Apply formal quality risk management principles (ICH Q9) across manufacturing and development activities • Build quality infrastructure that supports the transition from clinical to commercial supply, including commercial batch release processes, post-approval change management, and commercial QMS requirements • Balance compliance requirements with the practical realities of a fast-moving startup environment
Job Requirements
- BS., M.S., or Ph.D. in Pharmaceutical Sciences, Chemistry, Biology, or a related life science discipline; advanced degree strongly preferred
- 15+ years of pharmaceutical or biotechnology industry experience in quality assurance, with a significant portion in senior or lead CMC QA roles
- Has built CMC quality 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, quality 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 quality risk management principles
- Has led or co-led PAI preparation and been present during FDA inspections
- Experience supporting commercial batch release and post-approval change management
- Small molecule OSD experience required
- Comfortable operating without a large QA infrastructure — builds what's needed, prioritizes well, and doesn't wait for perfect conditions
- Strong written communication — produces clear, audit-ready 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.
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
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