GMP Quality Manager

Job Summary

To support day-to-day GMP QA operations, the contract remote GMP Quality Manager will provide QA oversight of Quality Control activities, collaborate on deviation investigations and CAPA plans, and partner with various functions to ensure compliance with quality systems.

Key responsibilities

• Provide QA oversight of all Quality Control activities, including test method validations and product specifications
• Collaborate with stakeholders on deviation investigations, CAPA plans, and documentation revisions
• Review and approve CMO documentation and perform product dispositions

Required qualifications

• Bachelor's degree in a scientific or technical discipline required
• Minimum 5 years of GMP Quality experience in the pharmaceutical industry
• Strong technical background in small molecule process development, validation, and testing
• Knowledge of applicable US and global GMP regulations and industry standards
• Ability to evaluate and troubleshoot complex technical problems independently