Director of Quality Compliance (Medical Manufacturing)

Cardinal Health

3d•$137,400 - $190,080

About The Position

Cardinal Health’s Global Medical Products and Distribution (“GMPD”) segment, focuses on U.S. and International Products and Distribution businesses. We offer industry expertise and an expanding portfolio of safe, effective medical products that improve quality, manage costs and reduce complexity. With our trusted regulatory experience, insights, and infrastructure, we help manufacture and source medical products that meet the demand for value-driven, comprehensive healthcare solutions. 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, and inspection readiness activities.

Requirements

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.

Nice To Haves

Ability to travel roughly 25%

Responsibilities

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.