💼 About This Role

You'll lead quality programs for Telix Pharmaceuticals' manufacturing expansion, ensuring compliance for radiopharmaceutical therapy lines. Your impact will drive safe, compliant delivery of life-saving cancer therapies. This role offers the chance to shape quality strategy in a fast-growing biotech.

🎯 What You'll Do

• Serve as Quality Program Lead for new radiopharmaceutical line buildouts and expansions.
• Establish and oversee program governance frameworks for capital projects.
• Own quality input into URS, design reviews, FAT/SAT, equipment qualification, and process validation.
• Embed inspection readiness into all program phases and ensure documentation readiness.

📋 Requirements

• Bachelor's or Master's in Engineering, Chemistry, Pharmaceutical Sciences, or related STEM field.
• 10+ years experience in pharmaceutical or biopharmaceutical manufacturing with capital projects or technical quality roles.
• Strong background in GMP operations with expert understanding of 21 CFR Parts 210/211/212.
• Demonstrated leadership in commissioning, qualification, validation (CQV), or tech transfer.

✨ Nice to Have

• Experience in radiopharmaceuticals or sterile/aseptic manufacturing.
• Familiarity with FDA expectations for facility design, data integrity, and inspection readiness.
• Knowledge of isotopes, hot cells, shielded systems, and GxP automation.

🎁 Benefits & Perks

• 🏖️ Remote work
• 💰 Competitive compensation
• 🏥 Health benefits
• 📈 Growth opportunities