Director, Quality Management - Pharma Repackaging & Private Label

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 operatio