Director, QRA Management

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

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.

What Quality Management contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Position Summary:

This includes oversite 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 of you and others at this level:

• Provides leadership to managers and experienced professional staff; may also manage front line supervisors
• Manages an organizational budget
• Develops and implements policies and procedures to achieve organizational goals
• Assists in the development of functional strategy
• Decisions have an extended impact on work processes, outcomes, and customers
• Interacts with internal and/or external leaders, including senior management
• Persuades others into agreement in sensitive situations while maintaining positive relationships

Anticipated salary range: $118,200- $199,980 Bonus eligible: Yes

Benefits:

Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close: 10/27/2026

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background.

We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day.

Cardinal Health is an Equal Opportunity employer.

All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. We are a crucial link between the clinical and operational sides of healthcare, delivering end-to-end solutions and data-driving insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care. With more than 50 years of experience, we seize the opportunity to address healthcare's most complicated challenges — now, and in the future.