Quality Control, Validation Lead

telixus; United States; On-site; USD 130,000 - 180,000; Full time

Job summary

Telix Pharmaceuticals is seeking a Quality Control Validation Lead to support startup, readiness, and compliant QC operations across the Telix Manufacturing Solution network. The role requires leading qualification, validation, method transfer, and equipment lifecycle across U.S.

sites, with extensive on-site travel. You will develop and maintain analytical methods, specifications, protocols, reports and QC documentation; review data, deviations, and CAPAs; and support regulatory submissions

Qualifications

• Bachelor's degree required in Chemistry, Biochemistry, Pharmaceutical Sciences, Analytical Chemistry, Microbiology, Radiochemistry, or related scientific discipline.
• Strong knowledge of FDA, ICH, USP and applicable regulatory requirements governing Quality Control laboratories and analytical testing 21 CFR 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.
• Willingness and ability to travel extensively (>75%) across multiple US manufacturing sites based on project schedules and validation timelines.
• Languages: English

Responsibilities

• 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
• 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 inspections
• Support analytical content for regulatory submissions and health authority responses
• 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.

Skills

QC Validation

Analytical Method Development

Regulatory Compliance

GMP

Travel Ready

Education

Bachelor's degree in Chemistry/Analytical Chemistry/Pharmaceutical Sciences/Radiochemistry

Advanced degree preferred

Job description

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

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. Travel will be driven by site startup, qualification, validation, method transfer, and operational readiness timelines.

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 wh