Job Description

AtomVie is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to empower the next generation radiotherapeutics for the detection and treatment of cancer and human diseases.
About the Role
Reporting to the Supervisor, Quality Assurance Tech-Transfer, the Senior Quality Assurance Associate - Tech Transfer will oversee technology transfer activities for both investigational and commercial products at AtomVie. This position will act as an interface between quality assurance, radiopharmaceutical development, regulatory, and production to ensure that all activities are conducted in compliance with relevant regulations and internal procedures.
What You Will Do

• Lead technology transfer and validation activities of investigational and commercial products and processes; including review and assessment of executed batches records and any relevant associated data (e.g., testing data OOS, non-conformances, change controls and CAPAs, etc.)
• Oversee assigned projects and when required execute project deliverables to ensure that high quality standards are met within the projected timelines and project outcomes are compliant with internal/external requirements and GMP regulations
• Represent AtomVie as the key Quality contact with client to develop approaches to compliance and address any issues in a timely manner
• Train, guide and support QA Operations once investigational and commercial products are ready for transfer, ensuring they successfully perform routine batch release, batch close-out and other associated QA activities
• Participate in client and internal project team meetings as subject matter expert to develop compliant approaches and address any issues in a timely manner.
• Detect, report, and proactively propose solutions to challenges to ensure compliance with AtomVie\xe2\x80\x99s internal standards as well as regulatory standards.
• Review standard operating procedures (SOPs), MBRs, STMs and other controlled documents for compliance with CAPAs, change controls, regulations and as per client requirements
• Review method, process validation and stability protocols for compliance
• Review related reports for compliance with protocols, quality systems, regulations and client requirements
• Participate in regulatory and client GMP inspections, as needed, and contribute to formal responses and CAPAs
• Conduct internal training of staff where needed
• Update job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; and participating in professional organizations
• Develop and maintain an in-depth knowledge of key regulations and guidance documents, pertinent to Product Development and Quality Assurance and use this knowledge to improve the quality management system
• Initiate and support improvement initiatives in favor of the development and growth of the AtomVie\xe2\x80\x99s quality management system.
• Support the growth and development of AtomVie\xe2\x80\x99s Quality Management System in accordance to Health Canada and FDA regulations, ICH Q10 and ISO guidance
• Complete any other related duties that support the core activities and mission of the Centre, as required

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Experience Required*

• Post-secondary education in Engineering, Chemistry, Microbiology or a Science field
• Minimum 5 to 7 years of relevant experience working in GMP/ Quality Assurance/ Method or Process Validation/Technology Transfer in the Biotech/Pharmaceutical/Radiopharmaceutical industry; experience in sterile products is considered an asset
• Deep understanding of Health Canada, FDA and EU GMP regulations

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What You Bring to the Role*

• You are an expert with Method & Process Validation or Technology Transfer
• Ability to lead improvements and interact with internal and external stakeholders
• Excellent communications skills in both written and spoken English
• Strong client-facing, teamwork and organizational skills

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AtomVie Offers: *

• Group Health & Dental Benefits
• RRSP Matching
• Transportation Reimbursement
• Training & Career Development
• Opportunity for long-term growth
• Join a passionate team making a difference in patients\xe2\x80\x99 lives

Job Type: Full-time