Site Quality Head, Florida (AD level)

Role Summary

Lead site quality strategy and organization for a new Radioligand Therapy manufacturing site in Winter Park, Florida. Build and develop a high-performing Quality team, ensuring inspection readiness, robust management of product quality issues, and continuous improvement to enable timely and safe delivery of life-changing therapies. Collaborate with site and global stakeholders to establish compliance with cGMP and regulatory requirements.

Responsibilities

• Lead site quality strategy and governance to meet Novartis standards and current Good Manufacturing Practice.
• Build, coach, and develop the Quality team, strengthening capability, engagement, and safe working practices.
• Drive plant startup, expansions, and technology transfer, ensuring compliant planning, commissioning, qualification, and validation activities.
• Lead inspection readiness and represent the site during health authority, corporate, and internal audits.
• Oversee deviations, investigations, out-of-specification events, and corrective and preventive actions through effective closure.
• Partner with Manufacturing and cross-functional leaders to enable compliant, efficient operations and risk-based decision making.
• Define and monitor site quality performance indicators, driving continuous improvement and timely escalation of risks.

Qualifications

• Required: Ten years of experience in a GMP pharmaceutical manufacturing environment, including laboratory operations and aseptic experience, and at least three years of combined relevant experience in Quality Assurance and/or Quality Control roles.
• Required: In-depth knowledge of cGMP and United States FDA regulations and International Council for Harmonization regulations. Understanding of US Pharmacopeia, European Pharmacopeia, and American Chemical Society standards.
• Required: Proven success leading health authority inspections and delivering robust remediation and sustained compliance improvements.
• Required: Demonstrated leadership in matrix organizations with excellent communication, organizational, and stakeholder management skills.
• Required: Experience applying continuous improvement methods such as Lean Six Sigma, Total Quality Management, and 5S workplace organization.
• Preferred: Prior experience with site start-up or rapid site expansion.
• Preferred: Experience or training in Radioligand Therapies, radiopharmaceuticals and/or radiation safety.

Education

• Bachelor’s degree in life sciences or a related scientific discipline.

Skills

• Leadership in matrix organizations with strong communication, organizational, and stakeholder management skills.
• Ability to develop and coach teams, drive inspection readiness, and manage quality systems.
• Experience applying continuous improvement methodologies (Lean Six Sigma, Total Quality Management, 5S).