Executive Director, Quality Assurance

Career Opportunities: Executive Director, Quality Assurance (5787)

Requisition ID5787-Posted10/20/2026-Cranbury, NJ-United States

Job Title - Executive Director, Quality Assurance

Department - Quality Assurance

Work Location - Cranbury NJ (On-site)

Position Summary

The Head of U.S. Quality provides strategic, scientific, and operational leadership for Quality Assurance and Quality Control across U.S. operations. The role is accountable for maintaining an effective, risk-based Quality Management System and ensuring that research, development, clinical, CMC, and manufacturing activities comply with applicable global regulations, industry standards, company policies, and client expectations. The position drives quality excellence, inspection readiness, organizational capability, and continuous improvement, with particular emphasis on biologics, commercial manufacturing, and complex CDMO operations.

Key Responsibilities

Strategic Quality Leadership

• Provide strategic and scientific leadership for the U.S. quality organization and execute the global Quality strategy in alignment with company standards, policies, and business objectives.
• Lead Quality Assurance and Quality Control functions supporting R&D, Clinical, CMC, technology transfer, manufacturing, and commercial operations.
• Embed quality considerations into strategic planning, new services, product development, site improvement, and organizational growth decisions.
• Serve as the senior Quality representative with clients, partners, regulatory authorities, external auditors, and industry forums.

Quality Management System and Compliance

• Establish, govern, monitor, and continuously improve a robust, risk-based Quality Management System and related procedural framework.
• Provide oversight of change control, deviations, investigations, CAPA, quality risk management, document control, training, validation, data trending, and management review.
• Ensure controlled documentation, including SOPs, master and executed batch records, validation protocols and reports, and technical reports, is accurate, current, and compliant.
• Identify and implement systemic improvements based on compliance trends, quality metrics, inspection outcomes, industry benchmarks, and emerging regulatory expectations.

Regulatory and Inspection Readiness

• Ensure ongoing compliance with applicable GxP and cGMP requirements, including FDA, EMA, NMPA/CFDA, ICH, USP, EP, and Chinese Pharmacopoeia expectations where applicable.
• Lead regulatory inspections and client audits, including inspection preparation, health-authority interactions, response strategy, remediation, and effectiveness monitoring.
• Maintain current knowledge of global regulatory requirements, industry trends, and best practices, and translate changes into timely updates to systems, procedures, and training.

Quality Assurance and Product Disposition

• Provide leadership and direction for QA oversight of manufacturing and laboratory operations, including batch record review, product disposition, quality events, and release decisions.
• Oversee review and approval of critical quality and technical documentation and ensure quality decisions are scientifically sound, risk-based, timely, and well documented.
• Facilitate quality risk assessments and mitigation plans to anticipate and address potential product, process, compliance, and supply risks.

Quality Control and Laboratory Governance

• Ensure Quality Control laboratories are appropriately equipped, staffed, and governed to support in-process, release, stability, and other required testing.
• Oversee analytical method development, qualification/validation, transfer, lifecycle management, laboratory investigations, and data integrity controls.
• Use laboratory and environmental monitoring trends, KPIs, and leading indicators to inform risk management, resource allocation, and improvement priorities.

Supplier, Material, and Client Quality

• Oversee supplier qualification, material quality, quality agreements, and the quality governance of raw materials and components used in manufacturing.
• Lead quality-related client communications, support client governance, participate in audits, and ensure observations and commitments are addressed effectively.
• Build trusted relationships with internal and external stakeholders while protecting compliance, product quality, patient safety, and client satisfaction.

Operational Excellence and Cross-functional Partnership

• Drive continuous improvement and operational excellence across Quality operations using data, trends, metrics, and appropriate prob