Director Quality Science & Technology

The Director, Quality Science & Technology (QS&T) is a senior quality executive accountable for portfolio‑level quality strategy, regulatory risk governance, and lifecycle readiness for biological drug substance, reagents, Complex Chemistry Molecules and associated services. This role ensures that quality, compliance, and patient’s safety are designed into products and sustained throughout the full product lifecycle, from concept and development through commercialization, post‑market surveillance, and obsolescence.

Serving as a key interface across PD, MS&T, Manufacturing, Supply Chain, Clients, Regulatory Affairs, and Global Quality, the Director QSAT drives consistent application of biological reagents and complex chemistry molecules quality system requirements, proactive risk management, and a prevention‑focused quality culture aligned with Agilent Therapeutic Division’s values and regulatory commitments. The role operates with significant autonomy, influencing outcomes through governance, technical authority, and executive partnership, rather than direct line management.

• Develop and own the portfolio‑level quality strategies and compliance strategy by applying Quality Risk Management principles to identify, assess and mitigate product, process and technology risks across Biological drug substances, Reagents & Complex Chemistry Molecule manufacturing operations.
• Serve as the accountable escalation point for material quality, regulatory, and patient/user safety risks impacting compliance, business continuity, or brand integrity.
• Provide risk‑based quality oversight and recommendations influencing product approvals, quality, compliance, market releases and supply reliability.

• Provide executive oversight of design control, risk management, and quality engineering practices for complex chemistry and biological drug substances, reagents, ensuring science-based design decisions, aligned with GMP requirements and regulatory expectations.
• Lead and govern risk management activities across development and implementation of new products, processes, and analytical technologies to establish robust control strategies and ensure product quality attributes are consistently achieved.
• Partner with PD, MS&T , Manufacturing, Engineering, QC, Clients and Regulatory teams to establish quality Principles in to process development, scale-up, technology transfer and life cycle management.
• Provide quality input into development protocols, validation strategies, specifications s to ensure readiness for GMP Manufacturing.
• Develop quality Engineers team to support client needs, compliance and regulatory requirements.

• Lead quality assessment of change controls, ensuring appropriate risk evaluation, impact assessment, validation requirement and implementation strategies are defined all changes.
• Define and apply risk‑based change control and lifecycle governance appropriate to regulated products.

• Maintain and evolve the Quality Management System (QMS) in alignment with complex chemistry molecules and biological drug substances, reagents regulatory requirements and applicable international standards.

• Identify and address systemic gaps that drive variability in compliance, product performance, or post‑market outcomes.
• Operate portfolio‑level quality governance and escalation mechanisms to ensure transparency, alignment, and timely executive decision‑making.

• Drive data‑driven continuous improvement using post‑market surveillance data, complaints, nonconformances, inspections, and audit outcomes.
• Lead initiatives to reduce Cost of Poor Quality (COPQ) while strengthening product reliability, compliance sustainability, and patient/user safety.
• Monitor post‑launch performance and champion preventive and systemic actions that improve long‑term portfolio health and regulatory resilience.

• Build and develop high‑performing QS&T and quality engineering teams with strong regulatory, technical, and risk‑based decision‑making capabilities.
• Provide strategic quality leadership and influence across teams to drive a proactive quality culture and effective risk-based approaches.
• Serve as a trusted quality and compliance leader during internal, customer, and regulatory inspections and audits.
• Communicate effectively with senior leadership, providing clear quality metrics, risk insights, and regulatory perspectives to enable informed business decisions.
• Lead complex quality discussions and facilitate alignment across manufacturing, QC, Manufacturing PD, MS&T, Regulatory, Engineering and Operations to enable complaint business decisions.

• Bachelor’s degree in engineering, Life Sciences, or a related discipline required; Master’s or PhD preferred

• 10+ years of experience in quality and technical operations, Process Development or manufacturing within biological and pharmaceutical environments.

• Demonstrated success managing quality and regulatory risk across biologics, peptides/polypeptides or complex biological product lifecycles, including development, launch, and post‑market sustainment.

• Proven ability to lead through influence, governance, and technical expertise in complex, global, matrixed organizations including CDMOs.

• Deep knowledge of complex chemistry and biological products system principles, risk management, validation, supplier quality, and statistical methods.

• Working knowledge of regulatory expectations (ICH,HC, FDA), GMP requirements, inspection readiness and applicable quality systems.

• ASQ certifications and/or Six Sigma credentials preferred.