Director, QRA Management

Cardinal Health•Aurora, CO

1d•Onsite

About The Position

The Director of QRA Management leads all quality activities for radiopharmaceutical manufacturing and testing operations at the Aurora, Colorado site. The role includes oversight of contract manufacturing organizations (CMOs), FDA inspections, quality systems, and regulatory compliance. The Director leads the quality team and drives cross-functional collaboration, reporting to the Vice President of Quality Management. The position provides quality leadership and decision-making for radiopharmaceutical manufacturing and testing, including Cardinal Health Nuclear & Precision Health Solutions products manufactured or tested by CMOs. It oversees quality documentation and processes, supports compliant and efficient achievement of manufacturing objectives, hosts FDA inspections, manages regulatory responses, and ensures regulatory commitments are implemented. The Director also leads people managers and individual contributors and ensures employees maintain required training, certifications, and qualifications in accordance with nuclear quality standards and regulatory requirements.

Requirements

Direct people leadership experience managing quality professionals.
Demonstrated leadership developing high-performing teams through training, qualification, certification, succession-planning, and talent-development programs.
Experience working in cGMP-regulated manufacturing environments, including compliance with 21 CFR Parts 210/211.
Nuclear radiopharmaceutical and pharmaceutical experience.
Excellent communication and stakeholder-management skills, including 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.
Ability to collaborate with cross-functional teams to achieve desired outcomes.
Ability to work in or relocate to Aurora, Colorado.

Nice To Haves

Bachelor’s and advanced degree in a related field, or equivalent work experience, preferred.
15+ years of experience in a related field, preferred.

Responsibilities

Lead Quality Management for the production facility.
Provide quality leadership for radiopharmaceutical manufacturing and testing activities, coordinating cross-functionally with site personnel to achieve manufacturing objectives efficiently and compliantly.
Oversee quality decision-making related to contract manufacturing and testing of Nuclear & Precision Health Solutions products, including Lymphoseek and Sestamibi.
Review and approve batch records, deviations and investigations, complaints, change-control requests, and related records for commercial products and products in development under CMO relationships.
Host FDA inspections, manage regulatory responses, and ensure implementation of regulatory commitments.
Lead and manage a team of people leaders and individual contributors.
Ensure employees maintain required training, certifications, and qualifications in accordance with nuclear quality standards and regulatory requirements.
Manage an organizational budget.
Develop and implement policies and procedures to achieve organizational goals.
Assist in developing functional strategy.
Interact with internal and external leaders, including senior management, and persuade others to agreement in sensitive situations while maintaining positive relationships.