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Head of Quality Assurance

3 months ago

Hamilton, Canada AtomVie Global Radiopharma Inc. Full time

About AtomVie Global Radiopharma Inc.

AtomVie Global Radiopharma Inc. stands as a premier GMP manufacturer and distributor of clinical and commercial radiopharmaceuticals. Our mission is to collaborate with partners to enhance patient outcomes through the development of high-quality therapeutic and diagnostic agents.

We pride ourselves on fostering a professional community that encourages growth, values collective achievements, and recognizes the significant impact we can have on our partners and patients worldwide. Join us in our commitment to transforming healthcare.

Position Overview

As the Head of Quality Assurance, reporting directly to the VP of Quality, you will spearhead the quality assurance initiatives for cutting-edge radiopharmaceutical products produced at AtomVie. Your primary responsibility will be to uphold and advance quality systems that facilitate the swift expansion of AtomVie’s contract development and manufacturing operations. You will collaborate closely with key departments, including Product Development, Operations, Regulatory Affairs, and Manufacturing, to provide expert guidance.

Your role encompasses overseeing quality assurance throughout the drug development lifecycle, from initial development to commercialization, ensuring that both clinical and commercial products meet stringent quality standards. You will lead efforts to guarantee compliance with relevant GxP (GLP, GCP, and GMP) regulations and any other applicable regulatory frameworks.

Key Responsibilities

  • Oversee all facets of Quality Assurance, driving initiatives for continuous improvement and ensuring adherence to regulatory standards set by Health Canada, FDA, and EMA.
  • Achieve operational objectives in Quality Assurance by managing daily activities, identifying issues, conducting audits, implementing changes, and providing feedback to management and stakeholders.
  • Act as the Quality Assurance representative for external clients throughout all phases of clinical development and commercialization.
  • Facilitate regulatory and client audits, ensuring timely involvement of internal stakeholders in corrective action processes.
  • Collaborate with the VP of Quality to develop and implement effective quality management system (QMS) processes in compliance with FDA, HC, EMA, ICH, QSR, and other relevant standards.
  • Promote a culture of quality within the organization, proactively identifying and addressing compliance risks.
  • Implement changes and regularly communicate quality system performance to employees and stakeholders.
  • Establish quality systems for the commissioning of new radiopharmaceutical production facilities and equipment.
  • Maintain up-to-date knowledge of regulations and oversee training for Quality Assurance staff.

Qualifications

  • Advanced degree (BSc, MSc, or PhD) in a relevant scientific field with a minimum of 15 years of QA experience in the pharmaceutical or biotech sector, including at least 5 years in a managerial role.
  • In-depth knowledge of cGMP pharmaceutical manufacturing operations in accordance with FDA, Health Canada, and EMA regulations for investigational and commercial products.
  • Experience in sterile manufacturing environments is highly desirable.
  • Proven track record in developing quality systems from inception in smaller, early-stage companies.
  • Competence in securing market authorization for new products, including managing pre-approval inspections.
  • Hands-on experience with electronic quality management systems, with a background in system selection and implementation being advantageous.

What We Offer

  • Comprehensive Health & Dental Benefits from the first day of employment.
  • RRSP Matching Program.
  • Access to Perkopolis.
  • Employee Assistance and Wellness Programs.
  • Parking Allowance.

Commitment to Diversity

AtomVie is dedicated to creating a workplace that values diversity, equity, and inclusion. We believe that a diverse workforce enhances our capacity for innovation and collaboration, enabling us to better serve our clients and patients. We appreciate your interest in a career with AtomVie. Only candidates selected for an interview will be contacted. Accommodations are available upon request for candidates participating in the recruitment and selection process.