Manager, Quality Control

📋 Description

• Oversee and coordinate assigned Quality Control reviews, ensuring clinical and regulatory documents
• Review, copyedit, proofread, and verify data across clinical and regulatory documents.
• Support QC review of various documents.
• Evaluate documents for content completeness, logical consistency, clarity, readability, formatting
• Identify missing information, inconsistencies, errors, and potential quality issues and collaborate
• Apply knowledge of pharmaceutical industry standards and regulatory requirements.

🎯 Requirements

• Bachelor’s degree required; graduate-level degree preferred.
• At least 5 years of relevant pharmaceutical or life sciences industry experience.
• Management experience preferred.
• Extensive experience reviewing or copyediting pharmaceutical regulatory documents.
• Experience with clinical sections of IND, NDA, MAA is a strong advantage.
• Thorough understanding of drug development and regulatory submission requirements.

🎁 Benefits

• Annual base salary: $111,100–$151,100
• Eligibility for annual bonus plan
• Opportunity for discretionary equity awards and Employee Stock Purchase Plan
• Comprehensive medical, dental, and vision insurance
• 401(k) retirement plan
• FSA/HSA options