Director, QRA Management

Cardinal Health•Aurora, CO

3d•$118,200 - $199,980•Onsite

About The Position

The Director, QRA Management leads quality activities for radiopharmaceutical manufacturing and testing operations at Cardinal Health’s Aurora, Colorado site. The role oversees contract manufacturing organizations (CMOs), FDA inspections, quality systems, and regulatory compliance, while leading the quality team and driving cross-functional collaboration. The position reports to the Vice President of Quality Management. The role provides quality leadership for production and testing activities, including oversight and decisions related to contract manufacturing and testing of Nuclear & Precision Health Solutions products such as Lymphoseek and Sestamibi. It reviews and approves batch records, deviations and investigations, complaints, change control requests, and related documentation for commercial and development products manufactured through CMO relationships. The Director hosts FDA inspections, manages regulatory responses, ensures regulatory commitments are implemented, and ensures employees maintain the training, certifications, and qualifications required to meet nuclear quality standards and regulatory requirements. This leadership position provides direction to managers and experienced professional staff, may manage front-line supervisors, manages an organizational budget, and develops policies and procedures to achieve organizational goals. It also contributes to functional strategy, makes decisions with extended impact on work processes and customers, and engages with internal and external leaders, including senior management. The anticipated salary range is $118,200–$199,980, and the position is bonus eligible. Cardinal Health offers a variety of benefits and programs supporting health and well-being.

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.
Strong 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 degree and an advanced degree in a related field, or equivalent work experience, preferred.
15 or more years of experience in a related field, preferred.

Responsibilities

Lead quality management for the production facility.
Provide quality leadership for radiopharmaceutical manufacturing and testing through cross-functional coordination with site personnel, ensuring manufacturing objectives are achieved efficiently and compliantly.
Provide quality oversight and make decisions regarding 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 documentation for commercial products and products in development under CMO relationships.
Host FDA inspections, manage regulatory responses, and ensure regulatory commitments are implemented.
Lead and manage a team of people leaders and individual contributors.
Ensure employees maintain required training, certifications, and qualifications to perform work 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.