Loyal

Role Description The Senior Director of Quality Control & Analytical Development will be providing strategic leadership for all analytical development and commercial quality control across Loyal’s pipeline and marketed products. You will oversee the full QC lifecycle from early development through commercialization, ensuring robust control strategies, regulatory compliance, and operational excellence. Builds and scales the QC/AD organization, leveraging internal and external partners, with deep expertise in OSD analytics and animal health regulatory requirements. Your daily work will include: - 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. Qualifications - 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.

• 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.

• 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.

• 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.

• Own the clinical development strategy for our portfolio of veterinary drug programs, including target product profiles, pivotal pathway planning, and key endpoints aligned with CVM expectations. • Build and manage detailed timelines for product development • Communicate strategy and development timelines across multiple teams within Loyal • Design companion animal clinical trials (pilot, field safety, and pivotal effectiveness studies) with appropriate statistical powering, endpoint justification, inclusion/exclusion parameters, and handling of operational constraints (e.g., heterogeneous populations, compliance variability). • Develop protocols, investigator brochures, SAP inputs, and essential documents tailored for investigators and staff in veterinary practice settings. • Work closely with statisticians on statistical design, randomization schemes, interim analyses, and data quality plans. • Partner with clinical operations to execute protocols with GCP compliance and serve as medical expert throughout in-life phase. • Provide medical and scientific oversight for all clinical studies, including: • Eligibility decisions • Case reviews and AE/SAE reporting • Protocol deviations and issue escalation • Interpretation of clinical data trends during trial execution • Support Clinical Operations with site engagement strategy, investigator training, and owner-facing communication frameworks. • Partner with Veterinary Affairs on real-world applicability, disease models, and clinician feedback loops. • Lead clinical components of regulatory interactions, including: • Pre-Submission meetings • Technical section responses • Study protocol reviews with regulators • Evidence summaries for FOI packages • Ensure that all clinical components meet VICH, GCP, and CVM guidance standards. • Work tightly with R&D to vet new drug targets and mechanisms and interpret pre-clinical data • Regulatory to align development plans with CVM requirements. • Veterinary Affairs to ensure clinic workflows and veterinary input shape study design. • Clinical Operations on execution strategy, site selection, and quality. • Commercial to ensure label-enabling claims are supported by data. • Lead clinical data review, analyses, and messaging strategy. • Develop authoritative veterinary medical clinical narratives for regulatory submissions, publications, and scientific communications. • Author study reports, abstracts and external presentations as needed. • Build and mentor a growing, high-functioning clinical development team with both veterinary medical and technical backgrounds. • Foster a culture of scientific excellence, operational pragmatism, and veterinary investigator-centered study design

• Own and drive Loyal's controllership function, including monthly close, CRO/CMO accrual reconciliation, technical accounting (ASC 606, 718, 842, 330; IRC §382; R&D tax credits), and audit management from auditor selection through signed opinion delivery. • Build inventory and cost-of-goods tracking ahead of commercial launch. Stand up gross margin reporting and the financial infrastructure required for a revenue-generating operation. • Build on and enforce internal controls while still enabling speed and judgment - purchase order requirements, contract approval workflows, and segregation of duties - documented for audit readiness. • Own the financial model. Build and maintain an integrated P&L, balance sheet, and cash flow model across pipeline programs, milestone timelines, and capital deployment scenarios. • Lead program valuation - NPV, DCF, and rNPV modeling - and support portfolio prioritization, partnering discussions, and Board capital allocation reviews. • Maintain a rolling cash runway model linked to program spend, headcount, and financing events. Track budget vs. actual at the department level; issue quarterly reforecasts with variance narratives. • Evaluate and implement an FP&A platform, integrated with QBO and providing department-level visibility. • Own the quarterly board finance package - standardized KPIs, variance analysis, and cash runway narrative - and provide regular financial updates to executive leadership and the board. • Populate data rooms, respond to investor and lender diligence requests, and prepare financial packages for capital partners. Support venture debt facilities and future financing events. • Partner with leadership on pre-board alignment, narrative framing, and capital strategy. Over time, assume primary ownership of investor-facing finance communications. • Build and manage contract processing workflows, the contract repository, and outside counsel relationships. Oversee vendor management and compliance filings. • Maintain the company's insurance portfolio - D&O, clinical trial liability, general coverage - reviewed annually and updated at financing events. • Manage in-house finance and people team and outsourced service providers. Ensure HR infrastructure is compliant across offer letters, onboarding, benefits, offboarding, and policy maintenance. Ensure payroll runs accurately across multiple states with equity compensation tracked correctly. • Lead ERP evaluation and migration when the company outgrows QBO.

• Authoring and reviewing regulatory submissions, including INAD filings, study reports, clinical trial evaluability meetings, and agency correspondence • Leading preparation for FDA CVM meetings, including  briefing documents, meeting requests, posing questions, and follow-up MOCs • Partnering with clinical teams to provide real-time regulatory guidance on active studies, including SAE submissions, BIMO preparedness, and NCIE reports • Reviewing and preparing study protocols, ICFs, and amendments to ensure the highest quality submissions for pivotal protocol concurrence • Monitoring and interpreting CVM guidance, policy updates, and precedent to inform Loyal's regulatory strategy across our pipeline • Anticipating and resolving regulatory risks across functions (including R&D, CMC, and commercial) throughout the portfolio before they become problems • Managing and mentoring 1–2 direct reports, providing feedback, priorities, and development support • Collaborating cross-functionally with R&D, clinical development, clinical operations, data management, and legal teams on submissions and strategy • Oversee the maintenance and organization of all regulatory records and interactions related to Loyal’s drug programs • Serving as the internal subject matter expert for any question touching FDA CVM clinical requirements — from study design to labeling to adverse event reporting  • Reviewing and advising on external facing pre-approval communications and activities to ensure compliance with FDA CVM regulations • Reviewing and providing guidance on labeling materials for submission to ensure compliance with FDA CVM regulations

• Own and drive Loyal's overall regulatory strategy across all active programs, including integrated CMC and clinical regulatory plans aligned with development milestones and commercial objectives, from early development through approval and post approval lifecycle management. • Provide regulatory input into portfolio planning, program prioritization, and business development activities, ensuring regulatory feasibility and risk are embedded in key decisions. • Develop and maintain global regulatory intelligence capabilities, monitoring evolving agency expectations, guidance documents, and industry precedents relevant to Loyal's programs and translating these into actionable strategy. • Provide regular regulatory updates and risk assessments to executive leadership and the board on submission progress, agency interactions, and regulatory risk. • Lead all CMC regulatory activities including filing strategy, CMC section authorship and review, post approval CMC change management, and regulatory oversight of manufacturing and CDMO partners. • Ensure CMC regulatory strategy reflects current agency expectations for small molecule OSD products and is integrated with CMC development plans and manufacturing timelines. • Partner with CMC and Quality leadership on CDMO regulatory readiness, including preparation for pre approval inspections and CMC related agency interactions. • Lead clinical regulatory activities including IND strategy and management, protocol regulatory review, study report oversight, and integration of clinical data into regulatory submissions. • Oversee regulatory strategy for pivotal studies and ensure alignment between study design, endpoints, and agency expectations to support a strong approval package. • Own the approval submission strategy and execution, coordinating across CMC, Clinical, and Quality to ensure submission ready packages that reflect current agency expectations and eCTD standards. • Serve as the company's primary liaison with regulatory agencies globally, leading the planning and execution of pre submission meetings, formal submissions, and ongoing agency communications. • Manage post approval regulatory obligations including periodic reports, labeling updates, post approval study commitments, and CMC variation filings, ensuring ongoing compliance with approval conditions. • Own labeling strategy and content development across the product lifecycle, ensuring labeling reflects agency requirements, clinical data, and commercial considerations, and is maintained in compliance with post approval obligations. • Establish and own Loyal's regulatory information management infrastructure, eCTD publishing capability, and submission archiving standards. • Build and lead a high performing regulatory organization, establishing clear functional ownership across CMC regulatory, clinical regulatory, submissions management, labeling, and regulatory operations. • Establish and scale regulatory governance frameworks and regulatory procedural documents — including submission templates, agency meeting management procedures, labeling review workflows, and regulatory decision documentation standards — that meet eCTD and global filing requirements and scale with the organization's growth. • Serve as the company's independent regulatory authority, with clear accountability to escalate regulatory risks, flag compliance concerns, and advise on activities where regulatory risk warrants executive attention. • Foster a culture of regulatory excellence and proactive risk management across the organization.

• 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

• 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