Site Quality Head, Texas (AD level)

Role Summary

Site Quality Head (Associate Director level) for a new Radioligand Therapy manufacturing site in Texas. Responsible for shaping the quality foundation, building a high-performing Quality organization, and ensuring inspection readiness, robust product quality issue management, and continuous improvement to support startup and scaling of the site. Partners with site and global stakeholders to deliver time-sensitive therapies safely and reliably.

Responsibilities

• Lead site quality strategy and governance to meet 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: Bachelor's degree in life sciences or a related scientific discipline.
• 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 Food and Drug Administration 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.