Associate Director of Quality Assurance

Job Summary

To provide Quality Assurance leadership for major sterile manufacturing capital projects, the remote Associate Director of Quality Capital Programs will oversee design, commissioning, and qualification phases while ensuring compliance with GMP and contamination control principles.

Key responsibilities

• Provide Quality Assurance oversight throughout the design, commissioning, and qualification phases of sterile manufacturing capital projects
• Lead GMP Design Reviews and Quality Risk Assessments to identify and mitigate contamination and compliance risks
• Collaborate with cross-functional teams to ensure quality requirements are integrated throughout project execution

Required qualifications

• Bachelor's or Master's degree in Microbiology, Engineering, Biological Sciences, Pharmaceutical Sciences, or a relevant scientific discipline
• Minimum 10 years of experience in sterile pharmaceutical manufacturing environments
• Strong knowledge of aseptic manufacturing processes and QC Microbiology
• Extensive experience with GMP regulations and contamination control principles
• Demonstrated expertise in conducting GMP Design Reviews and Quality Risk Assessments