QA Operations Lead

QA Operations Lead

Responsible for managing quality-related activities and projects within manufacturing operations at the Angleton site. This role ensures GxP compliance and alignment with Iso Therapeutics’ Quality Management Systems, supports overall quality oversight, and partners closely with site operations to maintain compliance, support day‑to‑day execution, and uphold regulatory and quality standards across radiopharmaceutical manufacturing activities.

• Understand and adhere to GMP Policies.
• Provide manufacturing quality oversight of all production, quality control, and supply chain departments, reviewing batch records and quality control results to ensure compliance with ITG quality and regulatory requirements.
• Perform live review of manufacturing batch records in preparation for batch release and promptly elevate any exceptions.
• Assist functional areas with achieving timely and compliant final product dispositions.
• Participate in writing, implementing, and approving Deviations, Investigations, CAPA, Change Control, and complaint reports.
• Ensure compliance of site personnel with aseptic techniques and sterile manufacturing regulations.
• Participate in supplier, vendor assurance activities and supplier quality agreements.
• Lead FDA/Regulatory interactions for the Angleton site activities and products to ensure successful regulatory submissions and inspections.
• Lead QA Operations as a valued business partner, fostering a culture of safety, quality, delivery to patients, cost control, compliance, and data integrity.
• Provide support to cross‑functional teams and assist other departments with exception management for compliance and timely closure.

• Bachelor’s degree in Life Sciences, Quality Management, or related field.
• 5+ years of experience in a quality assurance role.
• Experience in GxP manufacturing operations.
• Cross‑functional collaboration required.
• Ability to work in a team environment and communicate effectively with diverse groups.
• Willingness to work with radioactive materials and follow strict safety protocols.
• Technical understanding of manufacturing, quality and regulatory requirements.
• Previous experience writing and reviewing SOPs and specifications.

• Inclusive mindset; appreciation for diversity and commitment to an inclusive environment.
• Creativity and innovation; willingness to think outside the box.
• Commitment to excellence; take pride in work and strive for measurable results.
• Results‑oriented; driven to achieve goals and objectives.
• Ethical behavior; act with integrity.
• Adaptability; comfortable working in dynamic environments and reacting to changing priorities.
• Strong communication skills; effective at all levels.
• Collaboration; share knowledge and expertise to achieve common goals.
• Resilience; bounce back from setbacks.
• Continuous learning; seek ongoing professional development.

Competitive salaries, annual performance‑based bonuses, equity‑based incentive program, generous vacation, paid wellness days, and support for learning and development.

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.