Advisor, Quality Compliance

214 Cardinal Health 200, LLC; Columbus (OH); On-site; USD 82,000 - 105,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Short- and long-term disability

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health, Inc. in Columbus, Ohio seeks an Advisor, Quality Compliance Regulatory Management to develop and deploy policies and programs that minimize risk and enable compliant operations across the supply chain.

You will drive QMS deployment, guide operations on regulatory matters, and liaise with government agencies to maintain compliance. The role requires knowledge of 21 CFR parts and related regulations, with a track record in quality audits, CAPA, and risk assessment.

Qualifications

• Bachelor’s in related field or equivalent work experience.
• Preferred: CQA or other quality auditing experience.

Responsibilities

• Support implementation and execution of Cardinal Health Quality System at the Ohio Valley distribution center in Columbus.
• Lead non-conformance and CAPA investigations using Root Cause Analysis.
• Drive quality metrics and ensure processes are followed; participate in quality system audits.
• Provide guidance to operations on regulatory and quality matters; liaise with local, state, and federal agencies.

Skills

Regulatory compliance

Quality systems

Root cause analysis

CAPA investigations

Communication with authorities

Education

Bachelor’s degree in related field

CQA or quality auditing experience preferred

Job description

Advisor, Quality Compliance Regulatory Management is responsible for the development and deployment of policies, procedures and programs designed to minimize risk, enable compliant business operations, products and services and drive uncompromised supply chain integrity. Overview of Role: Demonstrates knowledge of regulatory requirements and utilizes depth and breadth of experience to assess regulatory changes, risk and business impact. Responsible for the implementation and execution of the Cardinal Health Quality System for the Ohio Valley distribution center located in Columbus, Ohio. Directs efforts to assess the implementation of Quality Management Systems (QMS) to drive performance improvement and enhance supply chain integrity while preserving and optimizing system efficiency. Applies thought leadership and expertise to assess, evaluate, manage, mitigate and balance risk and enhance business performance. Provides ongoing guidance and direction to operations personnel regarding regulatory and quality matters. Serves as liaison with local, state and federal government agencies. Experience with the multiple regulatory entities or regulations (21 CFR Part 205, 820, etc.; FDA, BOP, NABP, etc.) is desirable.

Responsibilities

This role reports to a Manager, Quality Compliance for Cardinal Health. Responsible for implementation of execution of activities necessary to support activities at the site.

Participates in the development policies and procedures to achieve specific goals. Works closely with Operations Leadership, LSS and other functional groups to initiate and drive change. Recommends new practices, processes, metrics, or models related to quality and regulatory programs. Leads non-conformance and CAPA investigations using Root Cause Analysis techniques and leading to sustainable corrective actions. Drives quality metrics and ensures processes are followed. Leads or participates in quality system audits. Provides solutions which may set precedent. Independently determines method for completion of new projects. Drives culture change and enhancement within facilities. Leads or participates in QMS projects, as directed. Other duties as assigned.

Qualifications

Bachelor’s in related field, or equivalent work experience, preferred CQA or other quality auditing experience preferred 4+ years experience in related field, preferred Experience with the multiple regulatory entities (21 CFR Part 205, 820, etc.; NABP, etc.) is desirable.

Salary and Benefits

Anticipated salary range: $82,100 - $105,480 Bonus eligible: No

• 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

Application window anticipated to close: 1/09/2027

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

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.

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