• Audit & Inspection Leadership • Lead regulatory inspections, notified body audits, customer audits, and third-party assessments, including preparation, on-site execution, response coordination, and remediation activities through closure. • Serve as the quality representative for external audit engagements, including direct interaction with regulators, customers, notified bodies, and auditors. • Quality Systems Execution & Improvement • Execute and improve assigned quality systems to ensure sustained inspection readiness, regulatory compliance, and effective audit performance. • Design, implement, and optimize quality system processes to sustain inspection readiness and regulatory compliance. • Apply regulatory requirements, industry standards, and customer expectations to develop practical, risk-based quality system solutions. • Identify quality system gaps, risks, and improvement opportunities through audit outcomes, trend analysis, and quality data review. • Design and implement quality system improvements informed by regulatory intelligence, audit feedback, and operational experience. • Quality Integration & Performance Monitoring • Support quality integration for new product introductions, platform deployments, technology transfers, and customer onboarding activities. • Partner with Development, Operations, Supply Chain, Regulatory Affairs, and Commercial teams to implement quality system requirements and improvements, • Establish and report quality metrics, trends, and management inputs to leadership. • Lead and develop quality systems staff though clear expectations, coaching, and performance management. • Provide oversight of electronic GxP quality systems, ensuring compliance and effective coordination with system administrators responsible for day-to-day configuration support. • Leadership & Management • Lead, manage, and hold accountable assigned Quality Systems personnel, including setting performance expectations, providing ongoing feedback, and conducting performance evaluations in alignment with organizational policies. • Identify capability gaps and support hiring, onboarding, and development activities to ensure the team can effectively execute quality system responsibilities. • QMS Oversight • The Director executes and oversees core elements of the QMS, with direct ownership of key activities, coordination of cross-functional inputs, and accountability for overall system performance, including but not limited to: • Quality Risk & Change Management (Change Management, CAPA, Investigations) • Product & Patient Impact Systems (Complaints, Field Alerts, Product Quality Investigations, APQR) • Documentation & Data Integrity (Document & Record Control, GxP Computerized System oversight) • Supplier & External Quality Oversight (Supplier Quality Management, Internal, Supplier, and Customer Audits) • Inspection Readiness & Regulatory Compliance Intelligence (Regulatory and Notified Body Readiness, Inspection Intelligence) • Quality Performance Monitoring (Quality Metrics, Trending, and Reporting)