Senior Specialist, GMP Quality Assurance

Kailera Therapeutics, Inc. seeks a Senior Specialist, GMP Quality Assurance to collaborate internally with QA, RA, and CMC departments and ensure oversight and compliance with external Approved Service Providers. The role requires review of GMP documentation, identification of quality issues, and compilation of data for Quality System Reviews.

Requirements

• 6+ years of experience in an FDA regulated Pharmaceutical Industry with GMP experience
• Understanding and knowledge of industry standards, concepts, current cGMP (21 CFR Parts 210 & 211 & Part 11 and EudraLex), and other agency standards and guidance as they relate to quality systems/quality assurance
• Experience with review of GMP manufacturing/packing records (Master/Executed Batch Records, Deviations, Change Controls, etc.) associated with Phase I-III clinical studies
• Proficient in Veeva QualityDocs and Veeva QMS a plus

Benefits

• Comprehensive health coverage
• Flexible time off
• Paid holidays
• Year-end shutdown
• Monthly wellness stipend
• Generous 401(k) match
• Tuition reimbursement
• Commuter benefits
• Disability and life insurance
• Annual bonus opportunities
• Equity grants