Quality Assurance Director

5 days ago

Hamilton, Ontario, Canada AtomVie Global Radiopharma Inc. Full time
About the Role

We are seeking a highly experienced Quality Assurance Director to lead our quality assurance program for innovative radiopharmaceutical products manufactured at AtomVie Global Radiopharma Inc. 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
  • Provide quality assurance oversight of drug development through commercialization, including the manufacture of clinical and commercial products.
  • Lead the quality assurance program and ensure compliance with applicable GxP (GLP, GCP and GMP) regulations and any additional applicable regulatory requirements.
  • Develop and implement effective, robust quality management system (QMS) processes and methods in alignment with FDA, HC, EMA, ICH, QSR and other requirements.
  • 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.
Requirements
  • BSc. /MSc. /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.
  • 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.
What We Offer
  • Group Health & Dental Benefits (from day 1)
  • RRSP Matching Program
  • Perkopolis
  • Employee Assistance and Wellness Programs
  • Parking Allowance

AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process.

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