Job Title - Executive Director, Quality Assurance
Department - Quality Assurance
Work Location - Cranbury NJ (On-site)
Position SummaryThe 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 ResponsibilitiesStrategic 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 problem-solving methodologies.
- Partner with Manufacturing, R&D, CMC, Clinical, Engineering, Supply Chain, Regulatory Affairs, and other functions to resolve complex quality issues and sustain compliant operations.
- Provide cross-functional support to ensure the sustainability and continual improvement of quality and compliance systems across the organization.
People, Organization, and Financial Leadership- Build, recruit, lead, and develop a high-performing, diverse Quality organization with clear accountabilities, succession plans, and capability-development priorities.
- Manage the employee lifecycle for direct reports, including selection, hiring, onboarding, goal setting, coaching, development, performance discussions, and recognition.
- Establish meaningful quality performance metrics and regularly evaluate organizational effectiveness, capacity, and capability against business needs.
- Prepare and manage the Quality budget and expenditures, and support capital expenditure requests for quality, laboratory, site improvement, and renovation needs.
Minimum Qualifications- Bachelor's degree or higher in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Biological Engineering, or a related scientific or engineering field; an advanced degree is preferred.
- At least 15 years of experience in the pharmaceutical or biotechnology industry, including at least 10 years in Quality leadership or Quality management roles.
- Extensive experience in a GMP-regulated biopharmaceutical, biologics, or CDMO environment; experience with antibody-drug conjugates is highly desirable.
- Demonstrated commercial manufacturing experience and broad knowledge of R&D QA, GLP, Clinical, CMC, Manufacturing QA, and QC environments.
- Proven experience leading cross-functional Quality organizations in complex, multi-site, or international settings.
- Deep knowledge of global GxP regulations, Quality Management Systems, regulatory inspections, and compliance frameworks.
- Experience interacting directly with regulatory authorities, clients, auditors, and strategic partners.
- Proven ability to lead large-scale programs, organizational change, quality improvement initiatives, and inspection remediation.
Leadership Competencies and Skills- Strategic and systems thinking with the ability to connect quality risk, regulatory expectations, operational performance, and business priorities.
- Strong people leadership, organization-building, coaching, succession planning, and change-management capability.
- Excellent communication, influencing, negotiation, and stakeholder-management skills at executive, client, and regulatory levels.
- Strong analytical, statistical, problem-solving, and decision-making skills for complex and ambiguous quality issues.
- Demonstrated commitment to quality culture, data integrity, scientific rigor, patient safety, and continuous improvement.
- Ability to operate effectively across cultures, functions, sites, and global time zones.
Physical and Travel RequirementsThe role may require occasional domestic and international travel to support client meetings, regulatory inspections, conferences, partner interactions, and oversight of external or multi-site quality activities.
Role Success Measures- An effective, sustainable, and inspection-ready Quality Management System.
- Consistent regulatory compliance and timely closure of audit, inspection, and quality commitments.
- Robust product disposition, laboratory, supplier, and quality-event governance.
- Data-driven continuous improvement and measurable reduction of recurring quality risks.
- A capable, engaged, and accountable Quality organization aligned with U.S. and global business needs.
- Strong, transparent, and trusted relationships with clients, regulators, partners, and internal stakeholders.
The salary range for this position is $160,000 - $260,000 
