Senior Manager, Quality Control

Job Title:

Sr. Manager, Quality Control (QC)

Reports to:

Director, Quality Classification:
Full-time, Exempt

Work Location:

Rochester, MN - Onsite Position Summary

The Senior Manager, Quality Control (QC) provides strategic, technical, and operational leadership for the Quality Control organization supporting radiopharmaceutical development and cGMP manufacturing operations in our Rochester, MN site. This role is responsible for building and scaling a high‑performing QC function that supports clinical and future commercial manufacturing within a fast‑paced and highly regulated CDMO environment. The Senior Manager, QC oversees the development, implementation, and continual improvement of analytical methods, laboratory systems, stability and environmental monitoring support activities, and compliance programs in accordance with Nucleus Radio Pharma standards, current Good Manufacturing Practices (cGMP), applicable FDA regulations, USP standards, and global regulatory expectations.

This leader is responsible for establishing and maintaining a science‑driven, inspection‑ready QC organization focused on operational excellence, data integrity, and sustainable compliance. The role oversees analytical testing, method qualification and validation, technology transfer support, laboratory investigations, OOS/OOT management, specification support, and regulatory inspection readiness activities supporting radiopharmaceutical manufacturing operations. As a key member of the site leadership team, the Senior Manager, QC partners cross‑functionally with Manufacturing, Quality Assurance, Regulatory Affairs, Technical Operations, Engineering, and client teams to support site readiness, process validation, commercialization initiatives, and the scalable growth of Nucleus Radio Pharma’s CDMO operations.

This position plays a critical role in enabling operational readiness, client success, and long‑term manufacturing excellence across the organization.

• Provide strategic and operational leadership for the Quality Control organization supporting radiopharmaceutical manufacturing and development activities.
• Build, develop, and mentor a high-performing QC team, including recruitment, onboarding, training, coaching, succession planning, and performance management.
• Lead the development, qualification, validation, transfer, and lifecycle management of analytical methods for radioactive drug products in a GxP environment, including radio-HPLC, TLC, GC, gamma spectroscopy, endotoxin testing, pH analysis and other analytical techniques.
• Oversee daily QC laboratory operations to ensure timely and compliant release testing, stability testing, raw material testing, environmental support testing, and client deliverables.
• Establish and maintain phase-appropriate QC systems, procedures, laboratory controls, and programs aligned with 21 CFR Parts 210, 211, and 212, USP requirements, and applicable ICH guidelines.
• Lead laboratory investigations, including Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, CAPAs, and root cause investigations, ensuring robust, scientifically sound, and timely resolution.
• Collaborate cross-functionally with Manufacturing, MSAT, Engineering, Regulatory Affairs, Supply Chain, Radiation Safety, and Quality Assurance to support product lifecycle activities and operational readiness.
• Support technical transfer, client onboarding, and startup activities for new radiopharmaceutical programs and manufacturing processes.
• Drive continuous improvement initiatives within QC operations focused on laboratory efficiency, compliance, data integrity, automation, and right-first-time execution.
• Develop and monitor QC performance metrics and KPIs, including laboratory turnaround times, deviation trends, CAPA effectiveness, and compliance metrics, reporting results to Quality leadership.
• Lead and support regulatory inspections, client audits, and internal audits, including preparation activities, inspection hosting, response development, and CAPA implementation.
• Ensure laboratory equipment qualification, calibration, preventative maintenance, and lifecycle management programs are established and…