Quality Director, Manufacturing Expansion & Readiness

Telix Pharmaceuticals

Remote
Remote
Gmp quality expertise
21 cfr parts 210, 211, and 212 compliance
Quality-by-design (qbd)
The Quality Director, Manufacturing Expansion & Readiness is a senior leadership role responsible for developing and driving the end-to-end quality program and establishing the program oversight for new radiopharmaceutical diagnostic and therapy manufacturing lines

Job Summary

  • The Quality Director, Manufacturing Expansion & Readiness is a senior leadership role responsible for developing and driving the end-to-end quality program and establishing the program oversight for new radiopharmaceutical diagnostic and therapy manufacturing lines.
  • This role integrates engineering program leadership with deep GMP quality expertise to ensure that all new processes, facilities, equipment, and technologies are designed, qualified, and operated in full compliance with 21 CFR Parts 210, 211, and 212 as well as additional applicable standards for radiopharmaceuticals.
  • Radiopharmaceutical therapy manufacturing demands the highest standards of precision, safety, and regulatory compliance.

Matching Summary

The Quality Director, Manufacturing Expansion & Readiness is a senior leadership role responsible for developing and driving the end-to-end quality program and establishing the program oversight for new radiopharmaceutical diagnostic and therapy manufacturing lines.

Skills & Requirements

Must-have

  • GMP quality expertise
  • 21 CFR Parts 210, 211, and 212 compliance
  • Quality-by-Design (QbD)
  • Risk-based decision-making
  • Commissioning/Qualification/Validation (CQV)
  • Radiopharmaceutical manufacturing standards

Nice-to-have

  • Inclusive mindset
  • Creativity and innovation
  • Commitment to excellence
  • Results-oriented
  • Adaptability

Key Requirements

  • 10+ years of experience in pharmaceutical or biopharmaceutical manufacturing
  • Significant experience in capital projects or technical quality roles
  • Preference in radiopharmaceuticals required
  • Bachelor’s or Master’s degree in Engineering, Chemistry, Pharmaceutical Sciences, or related STEM field

Work Rights

Not specified

Tailored Resume

Cover Letter