Principal Analytical QA Specialist, Drug Substance (Veterinary Pharmaceuticals)

Location: Remote - US; willingness to travel 10% required

Salary: $150,000–$190,000 per year

Company

hirify.global is a clinical-stage veterinary medicine startup developing longevity drugs intended to help dogs live longer, healthier lives.

What you will do

• Provide QA oversight for GMP manufacturing, analytical method development, qualification, validation, transfer, release testing, and stability programs.
• Review and approve validation protocols, raw data, reports, master and executed batch records, stability documentation, and other GMP records.
• Manage batch release and disposition activities for drug substance, drug product, packaging, and labeling.
• Lead or support investigations into deviations, OOS/OOT results, change controls, CAPAs, and other quality events.
• Support inspection readiness, supplier and audit programs, risk management, quality metrics, APR, field alert, withdrawal, and recall processes.
• Collaborate with Technical Operations, Analytical Development, Quality Control, CDMOs, CTLs, and CMC Regulatory Affairs on regulatory submissions and project timelines.

Requirements

• B.S. or M.S. degree in Pharmaceutical Sciences, Chemistry, Veterinary Science, or a related scientific discipline.
• At least 12 years of relevant pharmaceutical industry experience, including 6 or more years in GxP QA roles.
• Strong knowledge of FDA CVM regulations, cGMP, and VICH guidelines for veterinary products.
• In-depth experience with drug substance development and manufacturing, analytical methods, validation, release testing, stability programs, and quality systems.
• Experience managing CDMOs and collaborating across cross-functional teams in a matrix environment.
• Must be able to work remotely from the United States and be willing to travel 10%.

Nice to have

• RAC, ASQ, or other compliance and regulatory certifications.
• Experience auditing suppliers, CDMOs, and contract testing laboratories.
• Experience with electronic quality management systems and Google Workspace.
• Experience with small-molecule pharmaceutical development, solid oral dosage forms, or veterinary drug products.
• Experience with international regulatory environments such as the EU or Canada.

Culture & Benefits

• Full-coverage medical, dental, and vision insurance for employees and dependents.
• $1,000 home office equipment stipend and a $1,200 annual learning budget.
• $250 monthly wellness budget.
• Unlimited vacation, paid holidays, and extended four-day weekends for three-day weekends.
• Paid paw-ternity leave, company equity options, and a collaborative, transparent, high-agency work environment.