About this role
Role Overview
- Support and execute quality oversight activities for Clinical Trial Materials manufactured at external CMOs.
- Ensure consistent application of quality compliance by aligning daily activities with applicable cGMP regulations (US, EU, and other regions as required).
- Review batch documentation, supporting data, certificates of analysis, and technical reports for Finished Drug Product, clinical packaging, and labeling.
- Support batch disposition processes in accordance with established quality procedures and regulatory requirements.
- Facilitate and support deviation investigations, change controls, CAPAs, investigations, and nonconformance activities related to clinical manufacturing and external supply.
- Participate in inspection readiness activities and support internal, vendor, and regulatory audits and inspections.
- Identify, assess, and escalate product-related quality and regulatory issues and emerging trends.
- Work closely with Clinical Supply, Regulatory Affairs, Technical Operations, external Qualified Persons (QPs), and other stakeholders involved in external manufacturing and supply.
Requirements
- Bachelor’s degree in a related field.
- At least 3 years of relevant QA compliance and/or Quality Product Disposition experience in the pharmaceutical or biotech industry.
- Working knowledge of cGMP regulations.
- Experience reviewing manufacturing or clinical documentation.
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.