Director, Operational Excellence - Development Quality, Global Quality Operations

Om jobbet

At AstraZeneca, we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges.

Join us in Development Quality, a global function accountable for GMP Quality oversight across AstraZeneca's Pharmaceutical Technology & Development (PT&D) and Pharmaceutical Sciences organisations. You will play a central role in assuring the quality and compliance of investigational products that power our clinical development portfolio - including oversight of biologic IMPs for Phase III programs.

The role is placed at our dynamic R&D site in Gothenburg.

Your role
TheDirector, Operational Excellenceis a senior leadership role accountable for the performance, effectiveness, and continuous improvement of theDevelopment Pharmaceutical Quality System (PQS). As a member of the Development Quality Leadership Team, you drive the setting and delivery of the strategic direction for quality, operations excellence, and digital transformation.

You will lead a high-performing team of Development Quality Process Owners, owning end-to-end process design and execution. Your remit spans governance of the Pharmaceutical Quality System, global harmonisation, and inspection readiness. You'll boost productivity throughLeanandOperational Excellence, while advancing ourdigitalandAIcapabilities to enabledata-driven quality managementthat elevates performance and compliance across Development Quality.

You operate independently at global and local levels, influence senior stakeholders across Development and Operations. You provide decisive Quality Leadership, and make complex, risk-based decisions that directly affect product quality, patient safety, compliance, and business performance - while safeguarding AstraZeneca's external reputation.

Accountabilities/Responsibilities

• PQS Ownership and Performance: Accountable for the design, integration, maintenance, and continual improvement of the Development Quality PQS; ensures alignment with global policies, EU GMP/GxP requirements, ICH guidelines, and local regulatory expectations.
  
• Process Ownership: Leads and line-manages Development Quality Process Owners; accountable for process application, performance, effectiveness, and standardisation across sites; ensures clear process KPIs, ownership, governance, and lifecycle management.
  
• Governance and Management Review: Owns PQS governance forums, including Management Review and Issue Management Teams; ensures robust escalation, effectiveness checks, and closure of CAPA; assures data integrity and inspection readiness (including PAI).
  
• Quality Business Performance: Defines and tracks quality metrics/KPIs, drives performance improvements, and ensures alignment with Operations Quality; introduces predictive analytics to anticipate risks and prevent non-conformance.
  
• Operational Excellence and Lean: Champions a strong Lean culture; standardises and simplifies ways of working; leads cross-functional improvement projects; delivers measurable productivity, flow, and cycle-time gains without compromising compliance or patient safety.
  
• Digital, Data, and AI Enablement: Sets the digital strategy for Development Quality; leads deployment of digital tools, analytics platforms, and AI/ML use cases for PQS monitoring, deviation/capa intelligence, right-first-time, and predictive quality; ensures validated, secure, and compliant technology use.
  
• Strategy Development and Deployment: Co-creates and deploys the Development Quality Operational Excellence strategy; translates strategy into a multi-year roadmap with clear outcomes, milestones, and value delivery.
  
• Budgeting and Resource Management: facilitates function-level budgeting; manages headcount plans; ensures optimal resourcing and capability to meet current and future needs.
  
• Cross-Functional Leadership: Partners with Development functions, Operations Quality, Supply Chain, IT/Tech, and other Quality leaders to harmonise standards, remove barriers to work flowing across sites, and embed best practices.
  
• Risk Management: Embeds proactive quality risk management and robust change control; applies risk-based decision making to complex, ambiguous scenarios; assures continuous compliance during transformation.
  
• Communications and Stakeholder Engagement: Provides transparent performance reporting, communicates strategy and change clearly, and role-models Quality Leadership and business acumen.
  
• IT Applications in DevQ: Responsible for reliable operation of Development Quality IT applications related to PQS and process performance; sponsors development and validation of new tools and integrations.
  
• Team Leadership: Ensures the Operational Excellence and Process Owner team is effectively organised, resourced, and directed to deliver its accountabilities and roadmap.
  
• Capability and Development: Builds technical, digital/AI, data, and soft-skill capabilities; coaches and develops team members, fosters a high-performance, inclusive culture.
  
• Ways of Working: Establishes efficient processes and systems within the team; champions continuous improvement and knowledge management.
  
• Financials: Delivers against agreed financial and headcount targets; tracks benefits and value realisation from improvement and digital initiatives.
  

Essential Requirements - Education and Experience

• Functional & Business Knowledge: Scientific degree with experience in a pharmaceutical GMP environment, preferably within pharmaceutical development.
  
• Line Management: Proven experience managing direct reports and building high-performing teams across multiple countries, in both local and global settings.
  
• Leadership and Collaboration: Proven leader and collaborator with a track record of leading cross-functional teams, strong stakeholder management, and demonstrated change leadership.
  
• Quality Assurance Expertise: Experience in QA and PQS ownership or governance, with a broad understanding of Quality Systems, EU GMP/GxP, ICH, and the development lifecycle.
  
• Operational Excellence: Proven application of Lean, Six Sigma, and operational excellence methods to deliver measurable performance improvements in regulated environments.
  
• Digital and AI: Demonstrated experience deploying digital and AI/ML solutions in quality or manufacturing settings, including validated systems, data integrity, and change control.
  
• Business Acumen: Understanding of project/program management, portfolio prioritisation, budgeting, and supplier/partner management; familiarity with Supply Chain processes is advantageous.
  
• Fluent in English: Able to simplify complex ideas and influence at all levels.
  

Skills and Capabilities

• Leadership and Judgement: Demonstrates independent judgement, risk-based decision making, and the ability to act with courage and clarity in complex, ambiguous situations.
  
• Strategic Execution: Able to set high standards, convert strategy to action, and deliver outcomes at pace across multiple parallel workstreams.
  
• Communication and Collaboration: An excellent communicator who builds strong relationships across Development, Operations Quality, IT/Tech, and external providers.
  
• Lean Mindset: Drives standardisation, simplification, and continuous improvement; comfortable with visual management, daily management systems, huddles, and problem-solving routines.
  
• Digital Fluency: Deep understanding of data models, analytics, validation, and AI governance; comfortable translating business needs into digital requirements and value cases.
  
• Personal Credibility: High integrity and authenticity; energetic and resilient; able to inspire and develop teams while holding the bar for excellence.
  

Why AstraZeneca
It's a place to grow a fulfilling and exciting career with constant opportunities resulting from new products, technologies and growing areas like biologics. Our continued growth gives you greater exposure than anywhere else.

Are you ready to make a difference?Great, because we can't wait to hear from you! We look forward to your application no later thanFebruary 15th, 2026.

About AstraZeneca Gothenburg
Our stunning campus in Gothenburg is an incredibly vibrant and diverse place, with about 3,000 employees and a high proportion of international talent. Inclusion and diversity are embedded into everything we do, driving creativity and people empowered to innovate for patients by challenging conventional thinking. And the site itself has been designed with collaboration in mind. From the Coffee Lab to exercise areas, we've built a series of environments where innovation can happen.

Our Gothenburg site:https://www.astrazeneca.com/our-science/gothenburg.html
Follow AstraZeneca on LinkedInhttps://www.linkedin.com/company/1603/

Date Posted
30-jan.-2026
Closing Date
15-feb.-2026Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.