Remote Principal Analytical QA Specialist, Drug Substance

Description:

• Seeking an experienced Principal Analytical QA Specialist for Quality Assurance oversight of GMP manufacturing and lifecycle management of veterinary pharmaceutical products.
• Collaborate with Technical Operations and Analytical Development to ensure compliance with cGMPs, VICH, and global regulatory requirements.

Requirements:

• B.S./M.S. in a scientific discipline (Pharmaceutical Sciences, Chemistry, Veterinary Science, or related field).
• Minimum 12 years of pharmaceutical industry experience, with at least 6 years in GxP QA roles.
• Strong knowledge of FDA CVM regulations, cGMP, and VICH guidelines.
• In-depth knowledge of drug substance development, analytical method development, and quality systems.
• Experience managing CDMOs and collaborating across teams.
• Ability to work independently and meet deadlines.
• Willingness to travel (10%).

Benefits:

• Full-coverage health insurance for you and dependents.
• $1,000 home office equipment stipend.
• $1,200/year learning budget.
• $250/month wellness budget.
• 4-day weekends and unlimited vacation.
• Paw-ternity leave for adopting a dog.
• Competitive salary and company equity options.