Director, Commercial Product Quality

See Yourself at Telix

The Director, Commercial Product Quality plays a pivotal role in ensuring the highest standards of product quality and compliance within our commercial manufacturing operations. The scope includes intermediates, Bulk Drug or API, Drug Product, Packaging and Labeling, as well as Commercial Distribution. This leadership position requires a seasoned professional with a deep understanding of quality assurance, regulatory compliance, and a proven track record of success in the pharmaceutical or biotechnology industry. The successful candidate will be responsible for overseeing and enhancing quality management systems, driving continuous improvement initiatives, and collaborating with cross-functional teams to maintain and improve the quality of our commercial products.

Key Accountabilities

• Good Manufacturing Practices (GMP):
  • Demonstrate expert understandings with ICH and GMP standards from the larger health authorities worldwide, and guidelines governing the production of radiopharmaceuticals and medical devices.
  • Educates business partners on fit-for-purpose GxP requirements, ensuring a comprehensive understanding across teams.
• Pharmaceutical Quality Systems in Manufacturing:
  • Ensures manufacturing processes meet established quality standards through a formalized system.
  • Leads the department’s strategic quality improvement.
  • Ensures that PQS systems are aligned across sites within the organization.
• Quality Assurance and Control:
  • Utilize expertise to ensure that products meet quality standards, both during production and prior to release.
  • Collaborate with matrix teams on pipeline products, addressing Quality needs at the earliest stages of development.
  • Establishes an analytical framework for Quality problem solving.
  • Ensures that analytical problem-solving skills are continuously developed within the team.
• Regulatory Compliance:
  • Demonstrate in-depth knowledge of regulatory requirements in the life sciences industry and assures department is aligned with the most current regulatory expectations.
  • Leads companywide initiatives to improve continuous compliance.
  • Develops the overall regulatory compliance strategy for the organization.
• Documentation and Record-Keeping:
  • Ensures that documentation practices align with authority expectations within the department internally and with contract partners.
  • Collaborate with cross-functional business partners and third-party suppliers to ensure all required documentation is captured within Telix, meeting fit-for-purpose criteria.

Education and Experience

• Bachelor’s degree in a relevant scientific or engineering field required; advanced degree preferred.
• 12+ years of experience in quality within the pharmaceutical or biotechnology industry.
• 8+ years of leading people in the pharmaceutical or biotechnology industry.
• Proven experience in driving the continuous improvement of the pharmaceutical quality systems in a regulated environment.
• Drive strong team understanding of global quality standards.