Senior Director, Quality Control – Analytical Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and implement a comprehensive global analytical development and quality control strategy that aligns with Loyal’s corporate and CMC goals.

• Manage the complete analytical and QC lifecycle from initial development to commercialization, encompassing commercial QC readiness, product release, stability programs, and post-approval lifecycle management.

• Act as the lead executive for GMP analytical and QC operations, ensuring systems are inspection-ready and maintaining ongoing regulatory compliance.

• Function as a senior CMC leader within cross-functional program teams, shaping development strategies, timelines, and investment decisions.

• Oversee the development, validation, transfer, and lifecycle management of analytical methods and control strategies, focusing initially on small-molecule oral solid dosage products, while also supporting diverse modalities as the pipeline progresses.

• Drive the cross-functional identification and lifecycle management of critical quality attributes (CQAs), specifications, and control strategies.

• Establish and manage commercial QC operations, including oversight of external GMP testing laboratories and service providers.

• Provide executive oversight for deviations, investigations, out-of-specification/out-of-trend events, and CAPAs related to analytical and QC functions.

• Serve as a senior analytical subject-matter expert during interactions with the FDA Center for Veterinary Medicine (CVM) and other global animal health regulatory authorities, including handling regulatory submissions, responses, and inspections.

• Select, manage, and oversee external analytical laboratories, CDMOs (when applicable), and other partners to ensure technical performance, compliance, and cost efficiency.

• Build, scale, and lead a high-performing QC and analytical development team, which includes recruiting, mentoring, and cultivating senior technical leaders.

• Create operational models that effectively balance internal capabilities with strategic outsourcing to support an expanding commercial portfolio.

• Oversee resource planning, ensuring alignment of analytical and QC investments with pipeline priorities and long-term business goals.

⛳️ Requirements

• Ph.D., M.S., or B.S. in Analytical Chemistry, Chemistry, or a related scientific field.

• A minimum of 18 years of progressive experience in analytical development and quality control for pharmaceutical products, with extensive knowledge of small-molecule oral solid dosage forms.

• Proven experience throughout early development, clinical programs, commercial launches, and post-approval lifecycle management.

• Demonstrated success in building and leading analytical and/or QC organizations, which includes hiring, mentoring, and developing senior technical leaders.

• Significant expertise in analytical method development, phase-appropriate validation, method transfer, and GMP QC operations.

• In-depth understanding of animal health regulatory requirements, including FDA CVM and applicable global guidelines (e.g., VICH; ICH), with direct experience in supporting regulatory submissions and inspections.

• Proven ability to effectively oversee external GMP testing laboratories and analytical service providers, including governance, performance management, and resolution of quality issues.

• A strategic mindset capable of translating scientific and regulatory complexities into clear, actionable business recommendations.

• Comfort in a fast-paced, growth-oriented environment, balancing hands-on technical leadership with high-level decision-making.

• Exceptional communication and influencing abilities, enabling credible engagement 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 memberships, cleaners, spa services, food, etc.

• All 3-day weekends are transformed into 4-day weekends 🎉.

• Unlimited vacation and paid holidays.

• Paw-ternity leave — adopt a dog and receive a day off to bond with your new family member 🐶.

• Competitive salary.

• Company equity options granted to new hires.