Quality Assurance Director at AtomVie
AtomVie Global Radiopharma Inc.
Lead quality assurance initiatives at AtomVie Global Radiopharma Inc. in Hamilton, ON. This role focuses on compliance with GMP regulations and fostering a culture of quality across the organization. As the Quality Assurance Director, you will report to the VP of Quality and ensure the oversight of innovative radiopharmaceutical products. Your expertise will be key in developing comprehensive quality systems that support AtomVie’s growth in contract development and manufacturing operations. You will collaborate with various functional areas and lead efforts to drive operational excellence. Key Responsibilities:
- Oversee compliance of sterile manufacturing with Health Canada, FDA, and EMA guidelines
- Drive continuous improvement initiatives for quality assurance operations
- Serve as liaison with clients throughout clinical development stages
- Host audits and implement corrective actions in a timely manner
- Develop and enhance robust quality management system processes
- Minimum 15 years of QA experience in pharmaceutical industry
- At least 5 years in managerial roles with direct reports
- Strong understanding of GMP regulations for sterile products
- Knowledge of developing quality systems in early-stage companies
- Experience with electronic quality management systems
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