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.
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