Senior QA Leader, External Manufacturing (Remote)

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

Benefits offered by this job

Health insurance

Home office equipment stipend

Wellness budget

4-day weekends

Unlimited vacation and paid holidays

Paw-ternity leave

Equity options grant

Job summary

Loyal is seeking an experienced Principal QA Specialist, External Manufacturing to provide QA oversight of GMP manufacturing, release, validation, and lifecycle management for veterinary products. The role partners with CDMOs, Analytical Development, and Regulatory Affairs to ensure cGMP compliance and data integrity across global submissions.

Ideal candidates hold a B.S./M.S. in a scientific field, 12+ years in pharma with 6+ in GxP QA, and strong knowledge of FDA CVM, cGMP, and VICH.

Qualifications

• BS/MS in a scientific field; pharmacology or veterinary science is a plus.
• 12+ years in pharma with 6+ years in GxP QA.
• Solid knowledge of FDA CVM, cGMP, and VICH for veterinary products.
• Experience managing CDMOs and collaboration across cross-functional teams.

Responsibilities

• Provide QA oversight for GMP manufacturing, release, stability, validation, and lifecycle management.
• Review and approve protocols, reports, methods, and GMP documentation to ensure compliance.
• Manage batch release program with review of master/executed batch records and data.
• Lead investigations for deviations, OOS/OOT, CAPAs, and change controls with timely closure.
• Support regulatory submissions with data integrity assessments and cross-functional coordination.

Skills

GxP QA experience

FDA CVM regulations

cGMP knowledge

Regulatory affairs collaboration

CDMO management

Data integrity

Cross-functional teamwork

Education

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

Tools

Google Workspace

eQMS

Job description

Loyal is seeking an experienced Principal QA Specialist, External Manufacturing to provide QA oversight of GMP manufacturing, release, validation, and lifecycle management for veterinary products. The role partners with CDMOs, Analytical Development, and Regulatory Affairs to ensure cGMP compliance and data integrity across global submissions.

Ideal candidates hold a B.S./M.S. in a scientific field, 12+ years in pharma with 6+ in GxP QA, and strong knowledge of FDA CVM, cGMP, and VICH.