Quality Control, Validation Lead

Telix Pharmaceuticals (AMER); United States; Presencial; USD 120.000 - 160.000; Jornada completa

Descripción de la vacante

Telix Pharmaceuticals is seeking a Quality Control Validation Lead to support the startup and readiness of QC laboratories across the Telix Manufacturing Solution network. The role involves extensive travel across US sites to establish compliant QC operations, transfer and validate methods, and ensure regulatory readiness.

You will collaborate with Quality Control, Manufacturing, Technical Operations, and Regulatory groups to maintain inspection readiness and support regulatory submissions while

Formación

• Experience with analytical method development, validation, and transfer within GMP environments.
• Regulatory knowledge for FDA/ICH guidelines and 21 CFR 211/212.
• Strong data integrity and documentation practices.

Responsabilidades

• Lead QC startup, qualification, validation, and readiness across the network.
• Coordinate calibration, maintenance, qualification, and lifecycle of equipment.
• Develop and maintain GMP-compliant laboratory systems and data integrity.

Conocimientos

Analytical Method Development

Method Transfer & Validation

GMP Regulatory Compliance

Quality Systems & Documentation

Root Cause Analysis

Educación

Bachelor’s degree in Chemistry/Pharmaceutical Sciences

Advanced degree (M.S./Ph.D.) preferred

Herramientas

HPLC/LC-MS

Analytical Instruments

Descripción del empleo

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 your portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

See Yourself at Telix

The Quality Control Validation Lead supports the startup and readiness of Quality Control laboratories across the Telix Manufacturing Solution (TMS) network, providing technical and quality oversight for laboratory commissioning, qualification, validation, analytical methods, equipment, systems, and testing processes supporting clinical and commercial manufacturing. The lead partners with site Quality Control, Manufacturing, Technical Operations, Validation, Regulatory, and external laboratories to establish compliant QC operations, transfer and validate methods, qualify equipment, support regulatory submissions, and maintain inspection readiness.

This is a highly mobile, on-site role requiring more than 75% travel across multiple U.S. manufacturing sites, including stays of several weeks at a site.

Key Accountabilities:

Laboratory Startup & Readiness

• Support QC laboratory startup, qualification, validation, and operational readiness across TMS
• Coordinate equipment calibration, maintenance, qualification, and lifecycle
• Establish GMP-compliant laboratory systems, procedures, documentation, and data integrity
• Transition validated laboratories to on-site QC

Methods, Testing & Stability

• Lead analytical method development, transfer, verification, and validation for clinical and commercial
• Support technology transfers for new products, processes, and analytical
• Coordinate internal and contract laboratory
• Develop and maintain stability programs, protocols, and

Documentation, Compliance & Inspections

• Author and maintain analytical methods, specifications, protocols, reports, and QC
• Review analytical data, validation results, deviations, OOS/OOT investigations, CAPAs, and change
• Lead root cause analysis for analytical failures, atypical results, and quality
• Maintain readiness for regulatory inspections and internal or customer
• Support analytical content for regulatory submissions and health authority responses, as

Network Support & Travel

• Standardize and improve QC practices, analytical procedures, and validation approaches across the TMS

Travel more than 75% to provide on-site support for startup, qualification, validation, and commercial readiness.

Education and Experience:

• Bachelor’s degree required in Chemistry, Biochemistry, Pharmaceutical Sciences, Analytical Chemistry, Microbiology, Radiochemistry, or related scientific discipline. Advanced degree preferred.
• Strong knowledge of FDA, ICH, USP, and applicable regulatory requirements governing Quality Control laboratories and analytical testing 21FR 211, 212.
• Development, Validation, or GMP laboratory operations within the pharmaceutical, biotechnology or radiopharmaceutical industry.
• Demonstrated experience in analytical method development, method validation, method transfer, and analytical lifecycle
• Experience supporting laboratory investigations, OOS/OOT events, deviations, CAPAs, change controls, and regulatory inspections within a GMP environment.
• Experience authoring, reviewing, and approving analytical methods, specifications, validation protocols, reports, investigations, and GMP laboratory documentation.
• Willingness and ability to travel extensively (>75%) across multiple US manufacturing sites based on project schedules and validation timelines, including staying for several weeks on the site.
• Languages: English

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.

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