Global Regulatory Compliance Director
Core
Provide strategic leadership, governance, and stewardship of the global internal audit team and process for the Global Quality Systems group.
Role type
Senior IC Global Regulatory Compliance Director (Internal Audit)
Builds
Global internal audit program and quality system compliance
Domain
Medical Device / Quality Systems / Regulatory Compliance
Required skills
Global internal audit program leadership, risk-based audit strategy, quality system nonconformance management, regulatory change assessment, executive audit readiness, CAPA ownership, process improvement, executive decision-making
Responsibilities
Lead and develop a global team of quality system audit leaders; Define and deploy multi-year internal audit strategy; Provide strategic oversight for quality system nonconformances; Serve as global process steward for the Internal Audit process; Own the internal audit strategic process roadmap; Sponsor auditor capability building and training; Assess changes to standards and regulations; Provide executive leadership for external audit readiness; Deliver measurable process improvements; Sponsor and act as CAPA owner; Champion enterprise quality initiatives
Seniority
Director, strategic leadership & mentorship