RLT Quality Operations Lead US (Remote)

Role Summary

Are you ready to lead quality operations that directly impact patient safety and product excellence? As the RLT Quality Operations Lead for the US, you’ll shape the future of radioligand therapy manufacturing, championing best practices and driving innovation across multiple sites. This position can be based remotely anywhere in the U.S. with travel expectations defined by the hiring manager (approximately 25% travel).

Responsibilities

• Provide strategic leadership for quality operations across US radioligand therapy manufacturing sites.
• Define and implement the operating model for US quality operations, including organization design and performance management.
• Ensure compliance with current Good Manufacturing Practice (cGMP) standards and global quality policies.
• Ensure robust product quality oversight for RLT products, including radiopharmaceutical-specific controls, aseptic and sterile manufacturing practices, and distribution considerations; champion safety, ethical compliance, and patient-centric decision making in all quality activities.
• Lead inspection readiness and successful execution of health authority, customer, and internal inspections.
• Oversee site-level Quality functions (e.g., QA Operations, QC Laboratories, Batch Release, Deviation/Investigation Management, Change Control, Supplier Quality, Validation, Documentation Control).
• Partner with Manufacturing, Supply Chain, MS&T, Regulatory Affairs, EHS, and Global Quality to enable reliable, compliant supply to US and international markets.
• Drive harmonization of quality systems and digital tools across sites, promoting data integrity and lifecycle management.

Qualifications

• Required: Bachelor’s degree in a scientific discipline; advanced degree preferred.
• Required: Minimum 10 years of progressive quality experience in pharmaceuticals or biologics, with at least 7 years in radiopharmaceuticals or sterile/aseptic operations.
• Required: Previous experience as a Site Quality Head.
• Required: Working knowledge of FDA, EMA, and ICH regulatory requirements.
• Required: Proven track record of successful regulatory inspections, CAPA management, and quality system deployment.
• Required: Strong people leadership skills, including team building, talent development, and stakeholder management.

Education

• Required: Bachelor’s degree in a scientific discipline
• Preferred: Advanced degree