QC Manager

Role Summary

QC Manager in Indianapolis, United States. You will lead a high-performing Quality Control team, fostering scientific rigor and continuous improvement to ensure robust quality standards, reliable analytics, and seamless collaboration across manufacturing, quality assurance, and technical functions to deliver safe, effective radioligand therapies with speed and excellence.

Responsibilities

• Lead daily quality control laboratory operations to ensure timely, compliant testing.
• Guide and coach team members to strengthen technical skills and performance.
• Oversee environmental monitoring programs to maintain a sustained state of control.
• Review and approve laboratory data with a firm focus on data integrity.
• Drive investigations for deviations, out-of-specification results, and product complaints.
• Define, implement, and verify effectiveness of corrective and preventive actions.
• Support validation, technology transfer, and introduction of new analytical methods.
• Manage resource planning, equipment readiness, and workload distribution.
• Champion audit preparedness and represent quality control during regulatory inspections.
• Track key performance indicators and translate insights into continuous improvement.

Qualifications

• Required: Bachelor’s degree in a scientific discipline.
• Preferred: Advanced degree.
• Required: At least five years of quality control experience in pharmaceutical manufacturing.
• Required: Leadership experience managing a current good manufacturing practice laboratory.
• Required: Proficiency with inductively coupled plasma methods and high-purity germanium detectors.
• Preferred: Working knowledge of FDA regulations for radiopharmaceuticals.
• Required: Applied knowledge of Good Manufacturing Practice and relevant pharmacopoeial standards.
• Required: Demonstrated skill in deviation management and corrective and preventive action programs.
• Required: Experience with equipment qualification, calibration, and ongoing operational readiness.