Senior Director, Quality Control, Analytical Development
Loyal
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $230,000 - $280,000 per year
Job Level
About the role
- 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
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.
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
analytical developmentquality controlmethod developmentmethod validationGMP operationsregulatory submissionsanalytical method transferdata integrity21 CFR Part 11 complianceNADA filing
Soft Skills
leadershipstrategic thinkingcommunicationmentoringoversightproblem-solvinginfluencingresource planningcollaborationadaptability