Loyal

Compliance

• Responsible for building and leading cross-functional quality assurance systems across Loyal teams with an emphasis on FDA-CVM regulatory compliance for drug submissions and products.
• Own the design, administration, and continuous improvement of the electronic QMS, including validation status, user access, workflow configuration, and system health.
• Maintain, monitor, and continuously improve the company’s eQMS in alignment with GxP quality principles.
• Ensure eQMS documentation (e.g., SOPs, forms, work instructions, policies) is current, compliant, and effectively implemented across departments.
• Oversee document control processes, including drafting, reviewing, approving, and archiving quality documents.
• Drive periodic reviews and revisions of quality documents to ensure ongoing compliance and operational relevance.
• Own the CSV/CSA program for GxP computerized systems, ensuring systems are validated commensurate with risk and intended use.
• Review and approve validation plans, protocols, and summary reports for new system implementations, upgrades, patches, and configuration changes.
• Partner with IT/GxP Systems and system owners to define validation requirements for new tools and integrations before go-live.

Director, Quality Systems and Compliance

Research Scientist

• Lead end-to-end drug substance process development and manufacturing for small molecule APIs from synthetic route assessment and impurity control through scale-up, technology transfer, and commercial manufacturing readiness at CDMOs.
• Serve as the primary technical interface with drug substance CDMOs spanning partner selection, day-to-day oversight, troubleshooting, PAI preparation and performance management; ensure drug substance supply continuity, including second source qualification and starting material supply risk strategy, in support of clinical and commercial manufacturing.
• Lead RSM designation, ICH Q11 assessments, impurity fate and purge strategies and ICH M7 mutagenic impurity risk assessments; establish CQAs, CPPs, and ICH Q6A-aligned control strategies.
• Lead drug substance process validation from PPQ protocol development through batch execution and CPP/CQA verification; align PPQ timelines and batch disposition with drug product process validation and registration batch campaigns.
• Author, review, and approve drug substance CMC sections for regulatory submissions (VMF, INAD/NADA); represent drug substance CMC in agency interactions and ensure a technically integrated and consistent regulatory package.
• Partner with drug product development to translate drug substance CQAs into formulation design, excipient selection, container closure strategy and final dosage form decisions.
• Partner with analytical development to define method development, qualification, and validation strategy for drug substance release and stability testing.
• Partner with Quality to align drug substance specifications, batch disposition, and GMP compliance across CDMOs, and to support inspection and regulatory submission readiness.
• Manage drug substance post-approval change control strategy for manufacturing changes at CDMOs.

Senior Principal Scientist, Drug Substance

Chief Operating Officer

• Owning the operational execution of Loyal's first commercial launch in 2027 - partnering with organizations including Commercial, CMC/Supply Chain, Veterinary Medicine, and Creative to ensure a launch that performs commercially and earns a brand customers love.
• Leading Finance, People, Program Leadership, Commercial, Customer Service, and both Commercial and Internal/Platform Engineering. You will directly manage the leaders running each function, and build/scale the organizations where the organization is not yet built out.
• Scaling the company from ~70 to ~150 people with AI-leveraged efficiency — headcount growth gated to commercial milestones, not arbitrary expansion. Deploying AI tooling across ops, finance, recruiting, and customer service so leverage scales with the team.
• Iterating and owning the operating cadence the company runs on — goals system, weekly and monthly business reviews, and the board prep cadence.
• Owning the seam between commercial demand and technical supply — running the S&OP cadence with the CTOO so the CEO is not the integrator on day-to-day operational decisions.
• Leading product distribution platform buildout for a very complicated and regulated flow (prescription drug distribution), in collaboration with our engineering and commercial leadership.
• Building a customer service organization that scales with launch and that creates a pharma brand customers genuinely love.
• Acting as the company-wide problem solver — proactively identifying and resolving operational issues across functions before they become roadblocks.
• Freeing the CEO to focus ~80% of her time on external work (board, investors, partnerships, science narrative, brand) by the time of launch.