Quality Assurance Product Lead

See Yourself at Telix

The Quality Assurance Product Lead will provide QA leadership, oversight and support of Telix’s product disposition of commercial products manufactured and tested at contract manufacturing organizations and Contract Development Manufacturing organizations (CMOs and CDMOs). This position will ensure that Sponsor Quality oversight for commercial drug products as well as labelled and packaged products are completed on time and in accordance with cGMP, international regulatory requirements, internal policies, procedures and specifications. The Quality Assurance Product Lead will also lead Quality associated commercialization activities for late-stage development projects/products. This includes coordinating and leading the related activities with External Manufacturing, Regulatory Affairs, Operations, and Supply Chain to ensure Telix’s products are dispositioned on time to meet supply and customer requirements.

Key Accountabilities

• Develop and implement External Contract Manufacturing (ECM) execution and strategy from a quality perspective.
• Author, review, and approve documents within Telix Quality Management System (QMS).
• Provide oversight for deviations, investigations, CAPA and change controls with QA associates.
• Collaborate and partner with production / manufacturing / project / program management teams to monitor work according to requirements under Telix quality system.
• Assure vendor compliance with Telix quality and regulatory requirements by monitoring key quality deliverables and communicating clear expectations to key third parties. Lead escalation process for any issues requiring management decisions.
• Review and evaluate all standard operating procedures, batch records and quality control results to ensure compliance with Telix quality and regulatory requirements
• Act as the Quality Product Lead in meetings and discussions and the review of technical and other documents as required.
• Provide technical expertise and guidance to QA associates that are responsible for the release of manufactured batches.
• Support the release of commercial products as needed. Provide Quality leadership for the oversight of batch release.
• Act as the Quality Product Lead for cross-functional, local and global quality team discussions concerning product issues.
• Assure appropriate quality risk management principles are employed to ensure a level of compliance commensurate with stage of product lifecycle.
• Act as the Quality lead for investigational support associated with quality and technical issues and/or complaints and that these are completed in a timely manner.
• Personal development – maintain standard knowledge up to date with global GMP and regulatory requirements and make recommendations for professional development and training.

Education and Experience

• Bachelor’s degree in science related discipline (e.g., Chemistry, Biology, Pharmacology, Microbiology, etc.) required
• 5+ years’ experience in GMP within the pharmaceutical/biotechnology industry required
• Strong technical Quality background in API and Parenteral GMP manufacturing
• Ability to communicate effectively in all levels of an organization, especially with senior leadership
• Strong experience in quality from pharmaceutical/biotechnology industry
• Experience writing and reviewing Standard Operating Procedures
• Experience in reviewing and releasing manufactured batches
• Experience in writing, reviewing, and approving investigations and change controls
• Knowledge of applicable regulations (e.g., US FDA, EMA, ICH, PIC/S, WHO, etc.)
• Experience with quality risk management, reporting of non-conformances, CAPA management and change management.
• Radiopharmaceutical industry experience preferred
• Ability to travel domestically and internationally (approximately 30-50%)