Director of Quality Assurance

4 weeks ago

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

We are seeking a highly skilled Quality Assurance Director to lead our quality assurance program for innovative radiopharmaceutical products. As a key member of our team, you will be responsible for maintaining and further developing quality systems that support our rapid growth in contract development and manufacturing operations.

Key Responsibilities
  • Lead quality assurance oversight of drug development through commercialization, including the manufacture of clinical and commercial products.
  • Provide leadership and collaborate with all relevant functional areas to ensure compliance with applicable GxP regulations and any additional applicable regulatory requirements.
  • Responsible for all aspects of Quality Assurance, driving continuous improvement initiatives and providing oversight to ensure full compliance of sterile manufacturing operations.
  • Serve as the Quality Assurance liaison with external clients for projects at all stages of clinical development and commercialization.
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.
What We Offer
  • Group Health & Dental Benefits (from day 1)
  • RRSP Matching Program
  • Perkopolis
  • Employee Assistance and Wellness Programs
  • Parking Allowance

At AtomVie Global Radiopharma Inc., we are 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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