Manager, GMP Quality Assurance

Job Summary

A company is looking for a Manager, Manufacturing Product Quality (Small Molecule).

Key Responsibilities

• Oversee manufacturing of commercial and clinical products at contract manufacturers to ensure compliance with GMP and global regulatory requirements
• Perform batch record review and quality release activities for assigned products
• Collaborate with cross-functional teams to ensure timely and compliant delivery of materials and support deviation investigations

Required Qualifications

• Bachelor's degree in Chemistry, Engineering, Life Sciences, or a related field
• Minimum 5 - 7 years of experience in a regulated industry, with 3-5 years in Quality Assurance or Supplier Quality roles
• Familiarity with FDA 21 CFR Parts 210, 211, 820, and Part 11 requirements
• Proficiency in MS Word, Excel, and Access; experience with quality systems is a plus