Senior Analytical QA Lead – Drug Substance

Loyal; United States; Remote; USD 150,000 - 190,000; Full time

Benefits offered by this job

Health insurance (full coverage)

Home office equipment stipend

Wellness budget

Unlimited vacation

Equity options

Job summary

Loyal is seeking a Principal Analytical QA Specialist, Drug Substance to provide QA oversight of GMP manufacturing, release, stability, and validation across its outsourced network. You will review protocols, reports and GMP documentation, ensuring compliance with cGMP and regulatory standards for veterinary products.

Key responsibilities include batch disposition oversight, quality event investigations, data integrity assessments, and cross‑functional collaboration with CDMOs, CTLs, and

Qualifications

• BS/MS in a scientific discipline (Pharmaceutical Sciences, Chemistry, Veterinary Science or related field).
• Minimum 12 years in pharma with at least 6 years in GxP QA roles.
• Strong knowledge of FDA CVM regulations, cGMP and VICH guidelines applicable to veterinary products.
• Experience managing CDMOs and collaborating with cross-functional teams.

Responsibilities

• Oversee QA for GMP manufacturing, release, stability, validation, and lifecycle management of veterinary drug substances and products.
• Review and approve protocols, reports, analytical methods, and GMP documentation to ensure cGMP compliance.
• Lead or support investigations (CAPAs, deviations) and risk assessments with timely closure.
• Support inspection readiness, audits, and regulatory submissions with CDMOs/CTLs.

Skills

GxP QA leadership

FDA CVM knowledge

cGMP expertise

Regulatory submissions

Education

B.S./M.S. in Pharmaceutical Sciences, Chemistry, Veterinary Science or related field

Tools

Job description

Loyal is seeking a Principal Analytical QA Specialist, Drug Substance to provide QA oversight of GMP manufacturing, release, stability, and validation across its outsourced network. You will review protocols, reports and GMP documentation, ensuring compliance with cGMP and regulatory standards for veterinary products.

Key responsibilities include batch disposition oversight, quality event investigations, data integrity assessments, and cross‑functional collaboration with CDMOs, CTLs, and