Clinical Packaging Quality Manager

Job Summary

A company is looking for a Manager, Global Product Quality - Clinical Packaging.

Key Responsibilities

• Oversee clinical packaging operations to ensure compliance with GMP, GCP, and global regulatory requirements
• Support qualification and monitoring of external clinical packaging vendors, including audits and performance reviews
• Review and approve packaging documentation, ensuring proper implementation of packaging and labeling requirements

Required Qualifications

• Bachelor's degree in Chemistry, Engineering, Life Sciences, or a related field
• 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