Manager of Quality Assurance - Remote

Overview

The Senior Quality Assurance (QA) Representative will provide strategic quality oversight for outsourced drug substance, drug product, and/or quality control (QC) testing operations in support of biologics programs.

In Short

• Provide QA oversight for CDMOs and CTLs involved in biologics manufacturing.
• Review and approve batch records and testing results.
• Monitor compliance with quality agreements.
• Ensure robust root cause analysis and effective CAPA implementation.
• Maintain knowledge of global regulatory requirements.
• Support and lead regulatory inspections.
• Serve as the primary QA point of contact for outsourced operations.
• Provide guidance to internal stakeholders on quality and compliance.
• Identify and drive continuous improvement initiatives.
• Oversee data integrity compliance.

Requirements

• Bachelor’s or Master’s degree in Life Sciences or related field.
• 7+ years of QA experience in biologics or pharmaceutical industry.
• Deep knowledge of cGMP and global regulatory frameworks.
• Proven experience overseeing batch release and deviation investigations.
• Strong interpersonal skills and ability to influence.
• Experience with electronic quality systems.

Benefits

• Competitive salary range.
• Opportunity to work in a dynamic and collaborative environment.
• Contribute to innovative treatments for serious metabolic diseases.
• Engage in continuous learning and professional development.