[Hiring] Director of Quality Compliance @Cardinal Health

Role Description

The Director of Quality Compliance (Medical Manufacturing) oversees QMS compliance for the medical device business segment of Cardinal Health. This includes:

• Audit management (internal, external & supplier audits)
• CAPA governance
• Escalation management and field actions
• Inspection readiness activities

Responsibilities include:

• Oversees department operations with supervision of managers and professional employees.
• Develops process strategies to improve efficiencies and achieve specific goals.
• Partners with functional leaders on strategic improvements and communication.
• Develops policies and procedures to ensure the global QMS complies with all applicable regulatory and ISO requirements.
• Partners with other quality leadership functions to provide support where needed.
• Responsible for compliance scorecards and developing actionable metrics related to quality management and performance.
• Oversees auditing process and audit teams, including the Supplier Audit program and the Internal Audit program compliant with all applicable regulatory and quality requirements.
• Develops and implements an inspection readiness and support program to ensure ongoing audit-readiness.
• Supports global R&D activities ensuring that proper compliance guidelines are in place and being followed.
• Interactions normally involve resolution of issues related to departmental operations and/or projects.
• Gains consensus from various parties involved.

Qualifications

• 10+ years of progressive experience in Quality, Compliance, Regulatory Affairs, or related functions within an FDA-regulated industry (medical device, pharmaceutical, biologics, or combination products).
• Demonstrated experience leading and managing FDA inspections, including direct responsibility for responses to FDA Form 483 observations and Warning Letters.
• Strong understanding of FDA regulations, ISO standards, GMP requirements, and global quality compliance expectations.
• Proven track record developing and executing remediation plans, driving sustainable corrective and preventive actions (CAPA), and successfully resolving complex regulatory compliance issues.
• Deep knowledge of FDA Quality Management System Regulation (21 CFR Part 820/QMSR), ISO 13485, current Good Manufacturing Practices (cGMP), and global regulatory requirements applicable to medical device manufacturing.
• Demonstrated ability to lead organizational change, challenge the status quo, and successfully drive process transformation.
• Strategic thinker with the ability to translate vision into execution while balancing quality, compliance, customer needs, and business objectives.
• Exceptional communication and collaboration skills.
• Strong analytical and problem-solving skills with the ability to leverage data and insights to drive decision-making and influence stakeholders.
• Exceptional executive presence, communication, and relationship-building skills with the ability to influence across all levels of the organization and with external suppliers.
• Proven ability to manage competing priorities and lead through complexity in a fast-paced, matrixed environment.
• Ability to travel roughly 25%.

Requirements

• Anticipated salary range: $137,400 - $190,080
• Bonus eligible: Yes

Benefits

• 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