Quality Director, Manufacturing Expansion & Readiness

See Yourself at Telix

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.

The successful candidate will lead cross functional program governance, partner closely with functional support (Engineering, Operations, Validation, Regulatory Affairs, and Quality Control) and serve as the quality owner for major capital expansions and technology transfers.

Radiopharmaceutical therapy manufacturing demands the highest standards of precision, safety, and regulatory compliance. This role ensures that new lines are designed and implemented with a “Safety & Quality Always” mindset—enabling safe, reliable supply of life-saving therapies to patients.

Key Accountabilities:

• Program Leadership & Governance
  • Serve as the Quality Program Lead for new radiopharmaceutical diagnostic and therapy line buildouts, expansions, and modernization initiatives.
  • Establish and oversee program governance frameworks to ensure timely, compliant delivery of capital and engineering projects.
  • Communicate program status, risk, milestones, and escalation needs through structured reporting frameworks.
  • Drive integration of quality-by-design (QbD) and risk-based decision-making into design and construction activities.
  • Influence decision-making and ensure quality requirements are prioritized in schedule, scope, and budget tradeoffs
  • Ensure alignment with global quality strategy and senior leadership expectations.
• Quality Engineering & Compliance Oversight
  • Provide expert interpretation of 21 CFR 210/211/212 requirements to engineering and operations teams, ensuring compliant design of facilities, utilities, equipment, and processes.
  • Own quality input into URS development, design reviews, FAT/SAT execution, equipment qualification, and process validation.
  • Ensure facility and process design meets GMP expectations for sterile/aseptic operations, radiological controls, environmental monitoring, and contamination prevention.
  • Lead quality oversight of commissioning/qualification/validation (CQV) lifecycle, including master plans, protocols, deviations, and final reports.
• Inspection Readiness & Quality Systems Integration
  • Embed inspection readiness into all program phases; ensure documentation prepared through the project lifecycle meets regulatory expectations.
  • Drive development and integration of new lines into site Quality Systems (change control, deviations, CAPA, supplier quality, calibration, PM, training, etc.).
  • Partner with functions to ensure seamless operational readiness and smooth startup into routine production.
• Technical Leadership
  • Support risk assessments for equipment, utilities, materials, and processes (e.g., FMEA, HACCP, radiological risk assessments).
  • Guide development of master validation plans, control strategies (including contamination control strategy), IT infrastructure Part 11 compliant, and engineering standards for facilities, utilities, and equipment meet operational standards for diagnostics and therapies in radiopharmaceutical.
  • Apply knowledge of isotopes, hot cells, shielded systems, aseptic techniques, and GxP automation/EM systems.

Education and Experience:

• 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.

Leadership & Additional Competencies:

• Effective cross-functional leader with ability to influence without authority.
• Excellent communication skills, including executive-level program reporting.
• Strong project management and organizational skills.
• Ability to navigate ambiguity, manage competing priorities, and drive accountability across diverse teams.

Key Capabilities:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• 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
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new 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
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills