Associate Director Quality Assurance

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