Quality Director – Manufacturing Expansion, Readiness
Telix Pharmaceuticals Limited
full-time
Posted on:
Location Type: Remote
Location: United States
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Job Level
About the role
- Develop and drive the end-to-end quality program for new radiopharmaceutical diagnostic and therapy manufacturing lines.
- Ensure compliance with 21 CFR Parts 210, 211, and 212 as well as additional applicable standards for radiopharmaceuticals.
- Lead cross-functional program governance, partner closely with functional support teams, and serve as the quality owner for major capital expansions and technology transfers.
- Embed inspection readiness into all program phases; develop and integrate new lines into site Quality Systems.
- Support risk assessments for equipment, utilities, materials, and processes.
Requirements
- Bachelor’s or Master’s degree in Engineering, Chemistry, Pharmaceutical Sciences, or related STEM field required.
- 10+ years of experience in pharmaceutical or biopharmaceutical manufacturing, with significant experience in capital projects or technical quality roles. Preference in radiopharmaceuticals required.
- Strong background in GMP operations with expert understanding of 21 CFR Parts 210/211/212; additional experience with radiopharmaceuticals or sterile/aseptic manufacturing strongly preferred.
- Demonstrated leadership in commissioning, qualification, validation (CQV), or tech transfer.
- Deep expertise in quality engineering principles, risk management, and validation methodologies.
- Experience with modern facility and equipment design for radiopharmaceutical or sterile operations (e.g., hot cells, isolators, shielded IVT lines).
- Strong understanding of change control, deviation management, CAPA, and quality investigations.
- Familiarity with FDA expectations for facility design, data integrity, and inspection readiness.
Benefits
- Competitive salaries
- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GMP operationsquality engineering principlesrisk managementvalidation methodologiescommissioningqualificationvalidation (CQV)capital projectsradiopharmaceutical manufacturingsterile/aseptic manufacturing
Soft Skills
leadershipcross-functional collaborationprogram governanceinspection readiness