Associate Director Global Quality Systems

The Associate Director Global Quality Systems is a key global Operations role responsible for the end-to-end ownership, governance, and continuous improvement of core Quality processes and their supporting digital systems. Operating within a matrixed organization, the role leads a global process network to ensure standards, procedures, systems, and ways of working are aligned with cGMP, GxP, ICH, and internal Quality Management System requirements.

The role combines process leadership, quality systems expertise, compliance oversight, performance management, and digital transformation. The Associate Director Global Quality Systems drives standardization, simplification, harmonization, and innovation across the Cell Therapy enterprise, while ensuring processes remain inspection-ready, effective, and fit for purpose.

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 escalate 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. Complete all required training on the AZ Code of Ethics and supporting Policies and Standards on time. Report potential - issues of non-compliance.

Essential 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
• Direct Quality Systems and global experience
• Experience in other GXP areas (GLP, GCP)

Desired Requirements

• Direct Quality Systems and global experience
• Experience in other GXP areas (GLP, GCP)

The annual base pay for this position ranges from $129,556 – $194,335 Annual USD. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered include a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.  

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.