Director, QRA Management

Director Of Qra Management

The Nuclear & Precision Health Solutions division is committed to improving the lives of patients by applying roughly 50 years of experience and expertise in nuclear and precision health. The business provides radiopharmaceutical development, manufacturing, preparation, market access, and business solutions across the care delivery continuum from origin to patient administration. As the only national source for both SPECT and PET radiopharmaceuticals with the largest network of 130 pharmacies and 30 cyclotron facilities, we can reach 95% of U.S. hospitals within three hours.

We give customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas, so they can focus on their patients.

Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Management provides strategic oversight, leadership and direction within the Quality function.

Position Summary:

The Director of QRA Management leads all quality activities for radiopharmaceutical manufacturing and testing operations at our Aurora, Colorado site. This includes oversight of Contract Manufacturing Organizations (CMOs), FDA inspections, quality systems, and regulatory compliance. This role leads the quality team and drives cross functional collaboration.

The Director of QRA Management reports to the Vice President of Quality Management.

Responsibilities:

• Responsible for Quality Management of production facility
• Provide Quality leadership for radiopharmaceutical manufacturing and testing activities through cross-functional coordination with site personnel to ensure the total manufacturing objectives are accomplished in an efficient and compliant manner.
• Responsible for Quality oversight and decision making related to the contract manufacturing and testing of Cardinal Health Nuclear & Precision Health Solutions products including Lymphoseek and Sestamibi.
• Review and approval of all batch records, deviations/investigations, complaints, change control requests, etc. for the listed commercial products and those currently in development as part of a CMO relationship.
• Host FDA inspections, manage regulatory responses, and ensure implementation of regulatory commitments.
• Lead and manage a team of people leaders and individual contributors.
• Ensure all employees maintain required training, certifications, and qualifications to perform work in accordance with nuclear quality standards and regulatory requirements.

Qualifications:

• Bachelors and Advanced degree in related field, or equivalent work experience, preferred
• 15+ years' experience in related field, preferred
• Direct people leadership experience managing quality professionals
• Demonstrated leadership experience developing high-performing teams through robust training, qualification, certification, succession planning, and talent development programs, ensuring organizational capability and sustained regulatory compliance.
• Experience working within cGMP-regulated manufacturing environments, including compliance with 21 CFR Parts 210/211
• Nuclear radiopharmaceutical and pharmaceutical experience required
• Excellent communication and stakeholder management skills, with experience presenting quality performance, risks, and compliance matters to executive leadership, customers, and regulatory agencies.
• Experience serving as a primary quality representative during FDA inspections, customer audits, and regulatory reviews, with a track record of successful outcomes.
• Strong ability to collaborate with cross functional teams to drive desired outcomes.
• Ability to work in or relocate to Aurora, CO.

What is expected…