Senior Director, U.S. Quality

Job Summary

The Senior Director, U.S. Quality is responsible for leading and executing the Quality Management strategy across the U.S. business, ensuring compliance, operational excellence, and continuous improvement across all quality systems, processes, and products. This role partners closely with Global Quality leadership to translate enterprise quality frameworks into effective U.S.-specific execution, ensuring alignment with regulatory requirements, business objectives, and patient safety standards.

Key Responsibilities

• Lead U.S. Quality Execution

• Drive implementation of the Quality Management strategy across the U.S., ensuring alignment with global quality objectives and consistent execution across operations.

• Translate Global Strategy into U.S. Operations

• Adapt and implement global quality policies, processes, and systems to meet U.S. regulatory and business requirements.

• Regulatory & Compliance Leadership

• Ensure compliance with FDA and applicable regulatory requirements; lead U.S. inspection readiness and support regulatory interactions and audits.

• Operational Excellence & Continuous Improvement

• Champion continuous improvement across quality systems, including CAPA, deviations, complaints, and audit readiness.

• Risk Management & Issue Resolution

• Identify, assess, and mitigate quality and compliance risks; lead cross-functional efforts to resolve complex quality issues.

• Quality Systems Oversight

• Ensure effective implementation and ongoing performance of Quality Management Systems (QMS), including SOPs, policies, and metrics.

• Leadership & Team Development

• Lead and develop a high-performing Quality organization, typically through senior managers and managers, fostering strong leadership capability and accountability.

• Financial & Resource Management

• Manage the U.S. Quality budget, ensuring resources are effectively allocated to support compliance and business priorities.

• Cross-Functional Collaboration

• Partner with Manufacturing, Supply Chain, R&D, Regulatory Affairs, and Commercial teams to ensure integrated and compliant quality practices.

• External Engagement

• Support interactions with regulatory authorities and external partners as needed.

Differentiator

Leads a major functional area within a key market (U.S.), with significant impact on business operations and compliance outcomes. Implements and operationalizes global strategies within the region. Contributes to functional strategy through regional insights and execution excellence. Impact is primarily within region, with alignment to global objectives. Time horizon: 1–3 years, focused on execution, optimization, and continuous improvement. Typically reports to Global Head of Quality Management.

Responsibilities

• Leads teams primarily through senior managers and managers; may include limited director-level oversight depending on structure.

• Accountable for organizational effectiveness, talent development, and succession planning within U.S. Quality.

• Develops and executes operational plans (1–3 years) aligned with global strategy.

• Budget accountability for U.S. Quality.

Skills & Qualifications

• 14+ years of progressive experience in Quality within pharmaceutical/biotech or related industry.

• Demonstrated leadership experience managing teams and complex operations.

• Strong knowledge of U.S. regulatory requirements (FDA, GxP).

• Proven ability to execute strategy and drive operational excellence.

• Strong collaboration, influencing, and problem-solving skills.

• Advanced degree (Master’s or PhD) in a relevant scientific or technical discipline preferred.