Telix Pharmaceuticals (AMER)

Senior Manager, Commercial Product Quality (TLX250-CDx and TLX101-CDx)

USA- Remote · Senior

Sponsorship not specifiedDetected 16 days ago

Data AnalysisStatisticsComplianceSupply ChainGMPFDA RegulatoryLeadershipCommunicationCollaborationAdaptabilityGxP

About the role

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States.
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 Senior QA Manager, Commercial Product Quality plays a pivotal role in ensuring the highest standards of product quality and compliance within our commercial operations.

Educate business partners on fit-for-purpose GxP requirements, ensuring a comprehensive understanding across teams.
Maintain cross-functional relationships with key business partners to guarantee compliance across the scope of manufacturing operations.
Collaborate with matrix teams on pipeline products, addressing Quality needs at the earliest stages of commercialization.
Communicate and educate cross-functional business partners on regulatory expectations and provide analytical insights.

Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges

Bachelor's degree in a relevant scientific or engineering field required
advanced degree preferred
8+ years of experience in quality within the pharmaceutical or biotechnology industry
Knowledge of statistical techniques and methodologies for quality assurance
Strong understanding of global regulatory requirements, including FDA and EMA regulations
Demonstrated success in driving continuous improvement initiatives and achieving measurable results
Experience in risk management, root cause analysis, and CAPA (Corrective and Preventive Action) processes

Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
Telix Pharmaceuticals is an equal opportunity employer.

We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

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.

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