Senior Director Quality Assurance

Summary

The Senior Director of Quality Assurance - Operations provides executive leadership and strategic direction for global quality operations, ensuring consistent product quality, regulatory compliance, and operational excellence across manufacturing sites and the supply chain. This role is accountable for translating quality strategy into execution, embedding a culture of compliance and continuous improvement, and serving as a key partner to Operations, Regulatory Affairs, Supply Chain, R&D, and Commercial leadership.

The Senior Director operates with autonomy and decision authority, balancing risk, compliance, and business continuity in a highly regulated environment.

Reports to VP, Global Quality & Regulatory Affairs.

This position can be located in Libertyville, IL, or Ballina Ireland.

Responsibilities

• Define and execute the global Quality Assurance - Operations strategy aligned with enterprise objectives, regulatory requirements, and patient/customer safety.
• Serve as a key member of the Quality Leadership Team, providing input into enterprise risk management, business continuity planning, and long‑term operational strategy.
• Lead transformation initiatives to strengthen quality maturity, standardization, and scalability across global operations.
• Provide end‑to‑end leadership for Quality Assurance - Operations across multiple manufacturing sites, including Quality Assurance, Quality Control, Incoming Quality, Distribution Quality and Quality Systems execution.
• Ensure consistent application of quality standards, procedures, and governance across regions and sites.
• Oversee quality performance metrics, trend analysis, and management review to drive accountability and continuous improvement.
• Ensure ongoing compliance with applicable global regulations and standards (e.g., 21 CFR 820, ISO 13485, MDSAP, and applicable international or local requirements).
• Maintain a state of inspection readiness across all operational sites, act as sponsor for regulatory inspections and major audits.
• Provide oversight for critical quality events, including nonconformances, CAPAs, product holds, and field actions, ensuring timely and effective resolution.
• Lead cross‑functional response to significant quality issues, ensuring rapid containment, risk assessment, and mitigation.
• Serve as a decision authority for product disposition, escalation, and risk‑based decisions impacting quality, safety, supply, service, and regulatory commitments.
• Communicate quality risks and impacts clearly to executive leadership, enabling informed decision‑making.
• Partner closely with Operations, Supply Chain, Design Assurance, Regulatory Affairs, R&D, and Commercial teams to ensure quality is embedded throughout the product lifecycle.
• Drive alignment across functions during investigations, remediation activities, and improvement initiatives.
• Represent Quality Operations in enterprise forums, steering committees, and executive reviews.
• Drives standardization across the organization when appropriate
• Build, lead, and develop high‑performing global Quality Operations teams.
• Establish clear expectations, accountability, and succession planning for critical quality leadership roles.
• Foster a culture of ownership, transparency, and continuous improvement.

Essential Functions of the Role