Director, Pharmaceutical Quality Systems

Summary

Join Telix Pharmaceuticals as the Director of Pharmaceutical Quality Systems (PQS) and become a key leader responsible for overseeing and optimizing the company's comprehensive quality framework. This strategic role demands a seasoned professional with extensive experience in quality standards, regulatory compliance, and continuous improvement. You will develop and implement global strategies for documentation management and ePQS systems, ensuring compliance with GxP and ICH standards. Furthermore, you will lead internal audit programs, maintain data integrity, and foster a culture of quality across the organization. This position requires strong leadership, collaboration, and communication skills to work effectively with internal and external stakeholders. Telix offers a supportive and engaged work environment with competitive compensation and benefits.

Requirements

• Bachelor’s degree in a relevant field required (Quality, Life Sciences, Engineering, or related discipline)
• 10+ years of experience in quality and systems within the pharmaceutical or biotechnology industry
• 5+ years of people leadership within the pharmaceutical or biotechnology industry
• In-depth knowledge of GxP, ICH standards, and global regulatory requirements
• Proven experience in developing and implementing ePQS systems on a global scale
• Strong analytical and problem-solving skills, with a focus on continuous improvement
• Exceptional attention to detail and accuracy in interpreting and implementing regulatory requirements

Responsibilities

• Develop a strategy and execution plan to manage and store documents based on the needs of stakeholders and industry best practices while meeting standards including GxP and ICH
• Ensure the continuous improvement of documentation systems
• Develop a global strategy to roll out an ePQS system and associated business practices to administrative offices and company sites meeting the needs of stakeholders and industry best practices in all regions of the world
• Maintain the GxP Training System including assignment of training curricula, monitoring compliance to training, and reporting metrics to departments
• Following rollout, the system will be continually improved using a lifecycle model approach. Improved efficiency and simplicity will be key in the continuous improvement cycle
• Lead the department harmonization and standardization efforts
• Create a constant state of continual improvement by implementing a robust internal audit program based on requirements and guidance documents from the countries where we sell products
• Assure that the internal audit program is well connected to our inspection management program
• Create and maintain a robust data integrity program, including CSV, working with business partners especially IT
• Monitor progress and reports status as appropriate utilizing venues such as the Quality Management Review
• Ensure that all regulations guiding PQS and supporting program are aligned with our systems and business practices
• The ability to stay current with health authority requirements and industry best practices supporting a continual monitoring and improvement cycle of systems and business practices both internally and with our contracted suppliers
• Develop and lead the departments continuous improvement strategy
• The ability to interpret requirements, regulations, and company business strategy into actionable sizes allowing the creation of compliant and efficient systems and business practices in a timely manner
• Highlight areas of risk within our PQS for leadership, including actionable remediation plans
• Establish strong relationships with key stakeholders, both internal and external
• Maintain a focus of customer service listening to feedback for continual improvement and efficiency
• Proactively identifies and supports resolution of conflicts across functions and regions
• Create opportunities or forums for stakeholders to share and collaborate on innovative ideas in the spirit of continuous improvement
• Communicate the Quality vision and strategy across the company
• Take appropriate strategic risks to propel the organization forward while continuing to improve systems and embed efficiencies
• Promote a culture of accountability and continuous improvement throughout the organization
• Create platforms for knowledge exchange and collaboration across departments
• Champion change management best practices throughout the organization

Preferred Qualifications

Advanced degree preferred

Benefits

• Competitive salaries
• Annual performance-based bonuses
• An equity-based incentive program
• Generous vacation
• Paid wellness days
• Support for learning and development
• Hybrid and remote work options