About the roleWe're seeking an experienced Principal Quality Assurance Specialist, External Manufacturing to provide Quality Assurance oversight of GMP manufacturing, release, stability, validation, and lifecycle management activities supporting the development and commercialization of Loyal's veterinary pharmaceutical products. Operating within Loyal's fully outsourced manufacturing network, the position supports batch disposition of active pharmaceutical ingredient (API) / drug substance, drug product, packaging and labeling through review and approval of protocols, reports, analytical methods, and associated GMP documentation.
The role works collaboratively with Technical Operations and Analytical Development / Quality Control to ensure that the manufacture and laboratory analysis of drug substance, drug product, packaging & labeling of finished drug product conforms with cGMPs, VICH and global regulatory requirements. This position also partners with CMC Regulatory Affairs to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities.
Your daily work will include Manufacturing & Analytical Quality Oversight- Oversee all aspects of drug manufacture and testing through clinical development and into commercial phase.
- Provide Quality oversight for analytical method development, qualification, validation, transfer, release testing, and stability programs supporting drug substance and drug product development.
- Support establishment of phase-appropriate specifications, stability-indicating methods, and control strategies aligned with regulatory expectations.
- Review and approve validation protocols, raw data, and reports (for test method, process, cleaning, etc.).
Batch Release / Disposition & Quality Systems- Manage the batch release program by reviewing executed documentation, raw data, quality events (change controls, deviations, CAPAs, OOS/OOT investigations, risk assessments) and product disposition decisions.
- Review and approve master and executed batch records, analytical raw data, stability protocols, reports and data, and other documents to enable drug substance and final drug product release and on-going evaluation ensuring batches are compliant with cGMP requirements.
- Lead or support quality event resolution investigations (e.g., OOS/OOT results, deviations), ensuring root cause analysis, CAPA development, and timely closure.
- Support inspection readiness, audit programs, risk management, quality metrics reporting, Annual Product Review (APR) and product quality processes, Field Alert Report (FAR), product withdrawal, and product recall process.
Regulatory & Cross-Functional Support- Perform data integrity and compliance assessments including review against source documentation for regulatory submissions.
- Maintain effective communication with Contract Development and Manufacturing Organizations (CDMOs) and Contract Testing Laboratories (CTLs) to ensure Quality objectives are achieved in accordance with project timelines.
- Maintain awareness of evolving veterinary pharmaceutical regulations and ensure compliance strategies are updated accordingly
About you - B.S./M.S. degree in in a scientific discipline (Pharmaceutical Sciences, Chemistry, Veterinary Science, or related field)
- Minimum 12 years of relevant pharmaceutical industry experience, with at least 6 years in GxP QA roles.
- Strong knowledge of FDA CVM regulations, cGMP, and VICH guidelines applicable to veterinary products
- In-depth working knowledge of drug substance development and manufacturing, analytical method development, validation, release testing, stability programs, and quality systems.
- Experience managing CDMOs and collaborating effectively across cross-functional teams.
- Capable of working successfully in a team/matrix environment and independently, as required.
- Ability to meet deadlines, demonstrate efficient and effective use of time, and handle multiple assignments simultaneously.
- Ability to convey both written and verbal information effectively and efficiently.
- Demonstrated ability to follow procedures and perform assignments with a high degree of accuracy and careful attention to detail.
- Willingness to travel (10%).
Core Competencies:- Strong technical judgment and problem-solving
- Attention to detail and commitment to quality
- Excellent written and verbal communication
- Ability to influence cross-functional teams and external partners
- Effective project and time management
- Collaborative mindset with a continuous improvement focus
Preferred Qualifications:- Other Compliance or Regulatory certifications (e.g., RAC, ASQ) a plus.
- Experience auditing suppliers, CDMOs, and CTLs.
- Experience with Google Workspace applications (e.g., Sheets, Slides, etc.) and electronic Quality Management Systems.
- Experience in small molecule pharmaceutical development, routine analytical testing for solid oral dosage forms, and/or veterinary drug products preferred.
- Experience with international regulatory environments (EU, Canada, etc.) a plus
Salary Range: $150,000 - $190,000
Loyal 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
