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Telix Pharmaceuticals Verified
Biotechnology

QA Operations Lead

RemoteRemoteFull TimeLeadPosted 1 month ago

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Required skills

  • GxP
  • GMP
  • Quality Management Systems
  • SOPs
  • Batch Records
  • Quality Control
  • Regulatory
  • FDA
  • Sterile Manufacturing
  • Aseptic Techniques

Nice to have

  • Radiopharmaceuticals
  • Team environment

Role summary

Telix Pharmaceuticals is seeking a detail-oriented QA Operations Lead for its radiopharmaceutical quality team in Angleton. This role involves managing quality aspects and projects, ensuring GxP conformity, and supporting the Quality Management System for manufacturing operations. Key responsibilities include providing quality oversight for production, quality control, and supply chain; reviewing documentation like SOPs and batch records; managing deviations and CAPAs; leading regulatory interactions; and ensuring compliance with sterile manufacturing regulations. The ideal candidate has a Bachelor's degree in Life Sciences or related field, 5+ years of QA experience in GxP manufacturing, and strong collaboration and communication skills.

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

See Yourself at Telix

We are seeking a highly motivated and detail-oriented QA Operations Lead to join our radiopharmaceutical quality team. Our QA Operations Lead manages Quality aspects and projects within area of responsibility as well as ensuring and supporting overall GxP conformity and Compliance with the Telix IsoTherapeutics Quality Management Systems for the Angleton manufacturing site with a focus on the operation activities.

Key Accountabilities:

  • Understand and adhere to GMP Policies
  • Provide manufacturing quality oversight of all production, quality control, and supply chain departments to monitor all work according to requirements under ITG quality system. Review and evaluate all standard operating procedures, 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 escalate any exceptions immediately as requested by the quality system of the site.
  • Assist functional areas with achieving timely and compliant final product dispositions of the product being manufactured.
  • Participate in writing, implementing and approving Deviations, Investigations, CAPA Change Control and complaint reports.
  • Ensure compliance of site personnel and application of aseptic techniques and full compliance to sterile manufacturing regulations.
  • Participate in the management of 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, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity.
  • Provide support to cross-functional team and Assist other departments exception management for compliance and timely closure of exceptions.

    • Position Requirements

    Education and Experience:

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

    • Key Capabilities:

  • 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
  • Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to 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
  • Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
  • Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
  • Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
  • Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills

    • At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an 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.

    VIEW OUR PRIVACY POLICY HERE

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