Associate Director – Global Quality Systems

Jobtailor; California (MO); On-site; USD 150,000 - 210,000; Full time

Job summary

Jobtailor seeks a Senior Quality Leader for the Cell Therapy organization to design, govern, and continuously improve global quality standards, procedures, and processes across the enterprise.

You will lead global QMR, investigations, audits, and continuous improvement while ensuring cGMP/GxP compliance and partnering with Quality, Manufacturing, Regulatory, IT and other functions worldwide.

Qualifications

• Ten years of experience in a Quality environment with increasing responsibilities including Quality Systems.
• Strong knowledge of Cell Therapy Products and related Regulations and expectations.
• Self-directed and highly motivated team player with solid organizational capabilities.
• Deep knowledge of cGMP, GxP, and Quality Systems.
• Experience leading in a matrixed global environment.
• Process improvement mindset and Lean principles.
• Strong stakeholder management and cross-functional collaboration.
• Ability to translate business needs into process and system requirements.
• Experience with Quality digital tools and system implementation.
• Strong risk assessment, problem-solving, and decision-making capability.
• Excellent communication, coaching, and influencing skills.

Responsibilities

• Own global Quality processes: Design, govern, and continuously improve global standards, procedures, and business processes.
• Lead global organization in QMR, product complaints, Quality Investigations, audits, Risk, and Material Review Board for the Cell Therapy Organization.
• Ensure compliance: Maintain alignment with regulatory requirements, cGMP, GxP, ICH guidance, and internal quality standards.
• Lead a matrixed network of stakeholders across Quality, Manufacturing, Supply Chain, Regulatory, and IT to drive alignment and adoption.
• Drive process performance: Define and monitor global KPIs and improve compliance, efficiency, and user experience.
• Provide SME leadership: Guide and coach teams on Quality processes and standards.
• Support training: Develop and maintain training materials and curricula.
• Monitor compliance signals and risks: Review audits and deviations to identify risks and drive corrective actions.
• Lead inspection readiness and responses: Support internal and external audits and health authority inspections.
• Drive continuous improvement: Apply Lean to design and execution and promote best practices.
• Lead digital and system initiatives: Partner with IT to implement workflows and governance for Quality systems.
• Collaborate across PQS: Align processes and governance across AZ Quality System.
• Support strategic programs: Contribute to global projects and New Product Introductions requiring Quality leadership.

Skills

Quality management

Regulatory compliance

Cell therapy

Lean methodology

Stakeholder management

Cross-functional leadership

Risk assessment

Digital tools

Process improvement

Communication skills

Education

Bachelor’s degree in a scientific discipline

Tools

Quality software tools

Job description

Responsibilities

• Own global Quality processes: Design, govern, and continuously improve global standards, procedures, and business processes to ensure consistent implementation across the organization.
• Lead global organization in QMR, product complaints, Quality Investigations, audits, Risk, and Material Review Board for the Cell Therapy Organization.
• Ensure compliance: Maintain alignment of processes and procedures with applicable regulatory requirements, cGMP, GxP expectations, ICH guidance, and internal quality standards.
• Lead a matrixed process network: Engage and lead a global network of stakeholders across Quality, Manufacturing, Supply Chain, Regulatory, and IT to drive alignment, adoption, and consistent execution for Cell Therapy Network, aligning with Global BPOs and Global AZ Strategy.
• Drive process performance: Define and monitor global KPIs, evaluate process health, and implement actions to improve compliance, efficiency, and user experience.
• Provide SME leadership: Act as the subject matter expert for in-scope Quality processes, providing guidance, coaching, and interpretation of standards and procedural requirements.
• Support training and capability building: Develop and maintain training materials, role‑based curricula, certification requirements, job aids, and manuals to support effective implementation and sustained compliance.
• Monitor compliance signals and risks: Review audit observations, deviations, complaints, issue trends, and other process indicators to identify risks, drive corrective actions, and escape as needed.
• Lead inspection readiness and response: Support internal and external audits and health authority inspections, including inspection and responses to observations related to process and system compliance.
• Drive continuous improvement: Apply Lean principles to process design and execution, identify opportunities for simplification and harmonization, and promote the adoption of good practices and lessons learned.
• Lead digital and system initiatives: Partner with IT and business stakeholders to implement business requirements, workflows, and system needs for supporting Quality systems, including ongoing BAU governance.
• Collaborate across the PQS: Work closely with other Quality BPOs to align and integrate processes, systems, and governance across the broader AZ Quality System.
• Support strategic programs: Lead or contribute to global projects, transformation initiatives, and New Product Introduction activities requiring Quality process leadership.
• Conduct activities and interactions consistent with Company values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role.

Requirements

• 10 years’ experience in a Quality environment with increasingly responsible job requirements including Quality Systems
• Strong knowledge of Cell Therapy Products and Cell Therapy Specific Regulations and expectations
• Bachelor’s degree in a scientific discipline
• Self‑directed and highly motivated team player with solid organizational capabilities
• Deep knowledge of cGMP, GxP, and Quality Systems
• Experience leading in a matrixed global environment
• Process improvement and Lean mindset
• Strong stakeholder management and cross‑functional collaboration
• Ability to translate business needs into process and system requirements
• Experience with Quality digital tools and system implementation
• Strong risk assessment, problem‑solving, and decision‑making capability
• Excellent communication, coaching, and influencing skills