Quality Director

**Please note- this is an ONSITE position in Angleton, TX**

See Yourself at Telix

The Quality Director for North American Operations will provide Quality oversight and support of Telix’s radiopharmaceutical products manufactured at each site. This leadership position requires a seasoned professional with a deep understanding of Quality and a proven track record within the Pharmaceutical and/or Biotechnology industries. The Director will play a pivotal role in ensuring the highest standards of product quality and compliance within our development and commercial operational sites. This successful candidate will be responsible for overseeing and enhancing pharmaceutical quality systems, driving continuous improvement, and collaborating with cross-functional teams. This position will ensure that release activities for clinical and commercial drug substances and drug products are completed on time and in accordance with cGMP, international regulatory requirements, internal policies, procedures and specifications. This includes coordinating the related activities with External Manufacturing, Regulatory Affairs, Operations, and Supply Chain to ensure products are dispositioned on time to meet supply and customer requirements. This position will be based on site at our Angleton, Texas site and will also be responsible for multiple sites in the US and Canada.

Key Accountabilities

•  Good Manufacturing Practices (GMP)
  • Demonstrate familiarity and compliance with ICH and GMP standards from the major health authorities worldwide, and guidelines governing the production of radiopharmaceuticals
  • Educate business partners on fit-for-purpose GxP requirements, ensuring a comprehensive understanding across teams
  • Collaborate with internal production and manufacturing team, and external CDMOs to monitor work according to GMP requirements
• Pharmaceutical Quality Systems in Manufacturing
  • Ensure manufacturing processes meet established quality standards through a formalized system
  • Support manufacturing and project team in the use of the PQS
  • Identify gaps in Telix PQS and facilitate corrective and preventive actions as needed 
• 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 commercialization
  • Establish good housekeeping standards and ensure GMP facility and external storage locations adhere to FDA and ISO regulatory requirements
  • Work closely with contracted manufacturing, testing, or supply chain entities to align with Telix needs
• Regulatory Compliance
  • Demonstrate in-depth knowledge of PIC/S GMP requirements, ICH guidelines, 21 CFR 210, 211, and 212
  • Provide and assessment of risk when requirements cannot be completely integrated
• Documentation and Record-Keeping
  • Practice meticulous documentation and record-keeping to track activities, decisions, and transactions
  • Experienced in writing risk assessments and reviewing complex investigations
• Leadership
  • Connection
    • Develop strategies to enhance cross-functional collaboration
    • Create and maintain relationships and communication practices supporting common goals.
  • Creativity
    • Encourage cross-functional collaboration for generating new ideas
    • Problem-solve cross-functional issues to ensure appropriate relationships with contracted suppliers
  • Courage
    • Confront difficult issues with diplomacy and fairness
    • Facilitate decision-making, including risk assessment and analysis aligned with health authority requirements
  • Commitment
    • Build trust with stakeholders through transparent communication and consistent actions
    • Take ownership of actions and decisions, earning credibility through consistent delivery
  • Curiosity
    • Create opportunities for cross-functional collaboration and knowledge-sharing
    • Grow cross-functional relationships with diverse and efficient thinking, fostering creative approaches
  • Change
    • Align team goals with organizational change efforts
    • Navigate through periods of change in company prioritizations, encouraging resilience in others

Education and Experience

• Bachelor’s degree in Quality Management, Engineer, Life Sciences, or related discipline (or equivalent experience) required; Graduate degree is preferred
• 15+ years of experience in quality assurance, quality control, or development quality roles within the pharmaceutical, biotechnology, or medical device industry required
• 8+ years of leading people in the pharmaceutical or biotechnology industry required
• Demonstrated expertise in pharmaceutical quality systems (PQS), regulatory requirements (e.g., FDA, ISO), and industry standards (e.g., GMP, GLP)
• Experience managing quality-related projects, including developing quality plans, conducting risk assessments, and implementing corrective actions
• Strong problem-solving abilities with experience in root cause analysis, CAPA (Corrective and Preventive Action), and process improvement methodologies
• Excellent written and verbal communication skills, with the ability to interact effectively with cross-functional teams, stakeholders, and regulatory bodies
• Certifications such as Certified Quality Engineer (CQE), Certified Quality Manager (CQM), or Six Sigma Green/Black Belt preferred
• Experience with Medical Devices is preferred
• Ability to travel approximately 20% of time