Director, Quality & Regulatory Assurance

Cardinal Health; EE. UU.; Presencial; USD 118.000 - 200.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical coverage

Dental coverage

Vision coverage

Paid time off

HSA

401k

Flexible FSAs

Disability coverage

Parental leave

Wellness programs

Descripción de la vacante

Cardinal Health's Nuclear & Precision Health Solutions division seeks a Director of QRA Management to lead the quality team overseeing radiopharmaceutical manufacturing, testing, and regulatory compliance. You will coordinate with site personnel and senior leadership to meet manufacturing objectives.

This role requires 15+ years in quality within cGMP, experience with FDA inspections, and a track record of delivering compliant outcomes. Based in Aurora, CO, relocation may be required.

Formación

• Bachelor's 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.

Responsabilidades

• 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

Conocimientos

Leadership

Regulatory compliance

Quality management

Stakeholder management

cGMP expertise

FDA inspections

Cross-functional collaboration

Communication

Educación

Bachelor's/Advanced degree in related field

Descripción del empleo

Cardinal Health's Nuclear & Precision Health Solutions division seeks a Director of QRA Management to lead the quality team overseeing radiopharmaceutical manufacturing, testing, and regulatory compliance. You will coordinate with site personnel and senior leadership to meet manufacturing objectives.

This role requires 15+ years in quality within cGMP, experience with FDA inspections, and a track record of delivering compliant outcomes. Based in Aurora, CO, relocation may be required.