Director, Pharmaceutical Quality Systems

See Yourself at Telix

As the Director of Pharmaceutical Quality Systems (PQS), you will be a key leader responsible for overseeing and optimizing the comprehensive quality framework that underpins our organization's operations. This strategic role requires a seasoned professional with a deep understanding of quality standards, regulatory compliance, and continuous improvement methodologies. Working at the intersection of quality assurance, regulatory affairs, and operational excellence, you will play a pivotal role in shaping and sustaining a culture of quality within our organization.

Key Accountabilities:

• Documentation Management
  • 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.
  • Ensures the continuous improvement of documentation systems.
• Pharmaceutical Quality 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.
  • Maintains 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.
  • Leads the department harmonization and standardization efforts.
• Regulatory Compliance
  • 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
  • Creates and maintains a robust data integrity program, including CSV, working with business partners especially IT. Monitors progress and reports status as appropriate utilizing venues such as the Quality Management Review.
  • Ensures that all regulations guiding PQS and supporting program are aligned with our systems and business practices.
• Process Improvement and Continuous Improvement
  • 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.
  • Develops and leads the departments continuous improvement strategy.
• Attention to Detail and Accuracy
  • 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.
• Leadership
  • Connection
    • Establishes strong relationships with key stakeholders, both internal and external.
    • Maintains a focus of customer service listening to feedback for continual improvement and efficiency.
    • Proactively identifies and supports resolution of conflicts across functions and regions.
  • Creativity
    • Creates opportunities or forums for stakeholders to share and collaborate on innovative ideas in the spirit of continuous improvement.
    • Communicates the Quality vision and strategy across the company.
  • Courage -Takes appropriate strategic risks to propel the organization forward while continuing to improve systems and embed efficiencies.
  • Commitment - Promotes a culture of accountability and continuous improvement throughout the organization.
  • Curiosity - Create platforms for knowledge exchange and collaboration across departments.
  • Change - Champions change management best practices throughout the organization.

Education and Experience:

• Bachelor’s degree in a relevant field required (Quality, Life Sciences, Engineering, or related discipline). Advanced degree preferred.
• 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.

Key Capabilities:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills