Principal Quality Assurance Specialist, External Manufacturing

Loyal

2h • $150,000 - $190,000

About The Position

Loyal is seeking an experienced Principal Quality Assurance Specialist, External Manufacturing, to provide Quality Assurance oversight of GMP manufacturing, release, stability, validation, and lifecycle management activities for veterinary pharmaceutical products. The role 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 within Loyal’s outsourced manufacturing network.

The position collaborates with Technical Operations and Analytical Development / Quality Control to ensure that manufacturing and laboratory analysis comply with cGMPs, VICH, and global regulatory requirements. It also partners with CMC Regulatory Affairs to ensure the accuracy and integrity of data incorporated into Module 3 sections of CTD submissions and written responses to regulatory authorities.

Responsibilities include overseeing drug manufacture and testing through clinical development and commercialization; providing quality oversight of analytical methods and stability programs; supporting batch release and quality systems; resolving quality events; and supporting inspection readiness, audits, risk management, quality metrics, product quality processes, and regulatory compliance. The role maintains communication with CDMOs and CTLs and requires willingness to travel 10%.

Requirements

• B.S. or M.S. degree in a scientific discipline such as Pharmaceutical Sciences, Chemistry, Veterinary Science, or a related field.
• At least 12 years of relevant pharmaceutical industry experience, including 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.
• Ability to work successfully in a team or matrix environment and independently as required.
• Ability to meet deadlines, use time efficiently and effectively, and handle multiple assignments simultaneously.
• Effective written and verbal communication skills.
• Ability to follow procedures and perform assignments accurately with careful attention to detail.
• Willingness to travel 10%.
• Strong technical judgment and problem-solving skills.
• Attention to detail and commitment to quality.
• Ability to influence cross-functional teams and external partners.
• Effective project and time management skills.
• Collaborative mindset with a focus on continuous improvement.

Nice To Haves

• Compliance or regulatory certifications such as RAC or ASQ.
• Experience auditing suppliers, CDMOs, and CTLs.
• Experience with Google Workspace applications, such as Sheets and Slides, and electronic Quality Management Systems.
• Experience in small molecule pharmaceutical development, routine analytical testing for solid oral dosage forms, and/or veterinary drug products.
• Experience with international regulatory environments, such as the EU or Canada.

Responsibilities

• Oversee all aspects of drug manufacture and testing through clinical development and into the 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 phase-appropriate specifications, stability-indicating methods, and control strategies aligned with regulatory expectations.
• Review and approve validation protocols, raw data, and reports, including those for test methods, processes, and cleaning.
• Manage batch release by reviewing executed documentation, raw data, quality events, and product disposition decisions.
• Review and approve master and executed batch records, analytical raw data, stability protocols and reports, and other documentation to support drug substance and finished drug product release and ongoing evaluation.
• Lead or support investigations into quality events such as OOS/OOT results and deviations, ensuring root cause analysis, CAPA development, and timely closure.
• Support inspection readiness, audit programs, risk management, quality metrics reporting, Annual Product Review (APR), product quality processes, Field Alert Reports (FAR), product withdrawals, and product recalls.
• Perform data integrity and compliance assessments, including review against source documentation for regulatory submissions.
• Communicate effectively with CDMOs and CTLs to achieve Quality objectives in accordance with project timelines.
• Maintain awareness of evolving veterinary pharmaceutical regulations and update compliance strategies accordingly.

Benefits

• Full-coverage medical, dental, and vision insurance for employees and dependents.
• $1,000 home office equipment stipend.
• $1,200 per year learning budget for books, courses, and other learning.
• $250 per month wellness budget.
• Three-day weekends are extended to four-day weekends.
• Unlimited vacation and paid holidays.
• Paw-ternity leave: one day off when adopting a dog.
• Competitive salary.
• Company equity options grant for new hires.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal