Associate Director Quality Assurance

Job Summary

Providing Quality Assurance leadership for large-scale sterile manufacturing capital projects, the contract Associate Director Quality Assurance will oversee GMP quality requirements throughout the project lifecycle, collaborating with cross-functional teams in a remote capacity.

Key Responsibilities

• Provide Quality Assurance oversight for sterile manufacturing capital projects from conceptual design through commissioning and qualification
• Lead GMP Design Reviews and Quality Risk Assessments to identify and mitigate contamination control and regulatory risks
• Collaborate with Engineering, Manufacturing, Validation, and other stakeholders to ensure global regulatory compliance and successful project execution

Required Qualifications

• Bachelor's or Master's degree in Microbiology, Engineering, Pharmaceutical Sciences, Life Sciences, or a related scientific discipline
• Minimum 10 years of pharmaceutical industry experience, particularly in aseptic or sterile manufacturing operations
• Strong knowledge of QC Microbiology and contamination control principles
• Experience participating in Commissioning & Qualification (C&Q) activities
• Strong understanding of FDA, EMA, EU GMP, and other global regulatory requirements