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Quality Assurance Director
2 months ago
AtomVie Global Radiopharma Inc. is seeking a highly experienced Quality Assurance Director to lead our quality assurance program for innovative radiopharmaceutical products. The successful candidate will be responsible for maintaining and further developing quality systems that support the rapid growth of our business related to contract development and manufacturing operations.
Key Responsibilities- Lead the quality assurance program for radiopharmaceutical products, ensuring compliance with applicable GxP regulations and guidelines.
- Develop and implement effective quality management system (QMS) processes and methods in alignment with FDA, HC, EMA, ICH, QSR, and other requirements.
- Collaborate with cross-functional teams, including Product Development, Operations, Regulatory Affairs, and Manufacturing, to ensure quality assurance oversight of drug development through commercialization.
- Host regulatory and client audits, and assume responsibility for ensuring that internal stakeholders are included in establishing and implementing corrective actions in a timely manner.
- Establish quality systems for the commissioning of new radiopharmaceutical production facilities and equipment.
- Maintain current knowledge of regulations and take responsibility for Quality Assurance staff training.
- PhD in a relevant scientific discipline with 15 years' QA experience in the pharmaceutical/biotech industry, with at least 5+ years at a managerial level with direct reports.
- Proficiency in the English language, both written and oral, and excellent communication skills.
- Knowledge of maintaining a cGMP pharmaceutical manufacturing operation according to FDA, Health Canada, and EMA requirements for investigational and commercial products.
- Experience in a sterile manufacturing environment is a strong asset in this role.
- Experience in smaller, earlier stage companies developing quality systems from the ground up.
- Competent in achieving market authorization of new products, including the management of pre-approval inspections.
- Hands-on knowledge of electronic quality management systems is required, and experience in selection and implementation of a system would be an asset.
- Group Health & Dental Benefits (from day 1)
- A commitment to fostering a workplace that values diversity, equity, and inclusion.
