Director Quality Science

Job Description

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.

What you will be doing

Biological Drug Substances, Reagents & Complex Chemistry Portfolio Quality Strategy and Risk Ownership

• 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.

Design and Development Quality Leadership

• 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.

Lifecycle Readiness, Change Control, and Technology Transfers

• 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.

Quality Science & Technology Operations for 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.

Standards Application, Consistency, and Governance

• 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.

Post‑Market Performance, Continuous Improvement, and Compliance Sustainability

• 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.

Leadership, Influence, and Executive Engagement

• 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.
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