Loyal

VP, Quality Control – Analytical Development

Loyal

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $250,000 - $300,000 per year

Job Level

Lead

About the role

  • 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.

Requirements

  • 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 management.
  • Proven success building and leading analytical and/or QC organizations, including hiring, mentoring, and developing senior technical leaders.
  • Extensive experience with analytical method development, phase-appropriate validation, method transfer, and GMP QC operations.
  • Strong knowledge of animal health regulatory requirements, including FDA CVM and relevant global guidelines (e.g., VICH; ICH as applicable), with direct experience supporting regulatory submissions and inspections.
  • Track record of effective oversight of external GMP testing laboratories and analytical service providers, including governance, performance management, and quality issue resolution.
  • Strategic mindset with the ability to translate scientific and regulatory complexity into clear, actionable business recommendations.
  • Comfortable operating in a fast-paced, growth-stage environment, balancing hands-on technical leadership with executive-level decision-making.
  • Excellent communication and influencing skills, with the ability to engage credibly with executive leadership, regulators, and external partners.
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 controlGMP operationsanalytical method developmentmethod validationmethod transferstability programspost-approval lifecycle managementsmall-molecule oral solid dosageCQA management
Soft Skills
leadershipmentoringstrategic mindsetcommunicationinfluencingresource planningorganizational skillsexecutive oversightcross-functional collaborationproblem-solving
Certifications
Ph.D. in Analytical ChemistryM.S. in ChemistryB.S. in Chemistry