Associate Director – Global Quality Systems

AstraZeneca

Associate Director for Global Quality Systems ensuring compliance and governance in biopharmaceutical processes. Leading continuous improvement and digital transformation across quality systems.

Posted 7/8/2026full-timeGaithersburg • California, Maryland • 🇺🇸 United StatesSenior💰 $129,556 - $194,335 per yearWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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

Benefits

Comp & perks

health benefits including medical, prescription drug, dental, and vision coverage
paid vacation and holidays
paid leaves
qualified retirement program [401(k) plan]
short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality Process DesignRegulatory ComplianceKPI MonitoringLean PrinciplesQuality InvestigationsAudit ManagementTraining DevelopmentDigital Tools ImplementationMatrix LeadershipProblem-Solving

Soft Skills

Team PlayerOrganizational SkillsCommunication SkillsCoaching SkillsInfluencing Skills