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. Quality Management provides strategic oversight, leadership and direction within the Quality function.

Job Summary

The Director, Quality Management - Pharma Repackaging & Private Label plays a critical role at Cardinal Health to ensure products and processes consistently meet regulatory standards, customer needs, and internal performance benchmarks.  This role supports patient safety, quality compliance, and related regulatory operations for Cardinal Health businesses that repackage, relabel, and market prescription and generic pharmaceuticals, dietary supplements, and consumer products by implementing and monitoring quality systems and driving continuous improvement initiatives. By collaborating with cross-functional teams, quality management helps to identify risks, resolve issues proactively, and strengthen operational efficiency.  Ultimately, quality management enables us to deliver reliable, high-value products to our customers and their patients.

Responsibilities

Serves as the head of Quality for the business and is responsible and accountable for managing all aspects of quality and regulatory operations

Manages direct reports and broader quality and regulatory operations team and maintains team culture consistent with mission to support commercial enablement by ensuring quality and regulatory compliance

Develops and executes a long-term quality and regulatory strategy that aligns with business objectives, customer needs, and growth

Leads through influence to address quality and regulatory issues, while keeping sight of business goals

Leads and manages quality and regulatory function with agility through critical business events, crises or change

Defines and implements an effective quality system and risk-based quality and regulatory processes, procedures, and controls

Establishes goals, metrics, and KPIs to measure and report on quality system operations

Organizes and conducts appropriate management reviews with key stakeholders

Educates the business on quality and regulatory requirements

Works collaboratively with the business to support commercial objectives

Ensures effective supplier controls for third party suppliers including pharmaceutical and other manufacturers, contract repackagers, and stability laboratories

Ensures appropriate quality assurance oversight for contract repackaging facilities

Maintains stability testing program for repackaged pharmaceuticals

Establishes processes for and oversees investigations relating to stability testing, product complaints and other quality events

Establishes internal quality audit strategy and processes

Ensures compliance with relevant reporting and filing requirements such as drug listings, NDCs, establishment registration, CARES Act reporting

Supports regulatory assessments of new and current products

Supports the implementation of electronic quality system enhancements and other IT improvements

Fosters a strong quality culture, promoting accountability and continuous improvement

Drives continuous improvement initiatives within the quality system, leveraging metrics and trends to identify opportunities for enhancement

Stays abreast of emerging regulatory trends and industry best practices that may impact the business

Qualifications

12+ years of experience preferred

Bachelor’s degree in related field or equivalent work experience preferred

10+ years pharmaceutical manufacturing or repackaging related work experience preferred

10+ years quality or regulatory related work experience preferred

Excellent written and oral communication skills, capable of effectively presenting complex information to diverse audiences, including senior management and regulatory bodies

Strong understanding of FDA regulations and relevant ICH and compendial requirements

Extensive experience in leading and hosting regulatory inspections (e.g., FDA, state boards) and customer audits

Experience with conducting internal and external (supplier) quality audits

Demonstrated expertise in managing product complaint investigations and leading product recall processes

Knowledge of validation principles for equipment, processes, and cleaning, particularly relevant for repackaging operations

Strong background in managing change control systems, deviations, CAPA, and OOS investigations

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

Proactively identifies risks and identifies and implements strategies to mitigate and address those risks

Collaborates and works cross-functionally to address complex problems and provides leadership to ensure compliance and support business goals

Anticipated salary range: $116,500 - $188,055

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: 9/24/25 *if interested in opportunity, please submit application as soon as possible.

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.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

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/Affirmative Action 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.

To read and review this privacy notice click here