Director, Strategic Quality Management

This is what you will do:

• As the Director of Strategic Quality Management, you will lead quality efforts, ensuring that the Alexion GMP QMS and relevant regulatory requirements are met by all International Regulatory (RA), Country Regulatory and Quality Affairs (CRQA) and Global RA functions.
• You will play a crucial role as a key member of the Country/Affiliate Strategic Quality Management (SQM) Team, actively promoting a Quality Culture in collaboration/patnership with international RA, CRQA teams and Global RA teams. This involves fostering a quality mindset, facilitating learning, and driving sustainable continuous improvement.
• Contribute to defining, monitoring, and continuously improving KPIs/metrics to enhance overall quality performance within International RA, CRQA and Global RA.
• Collaborate with International RA, Global RA, CRQA, Quality Business Partners (QBRs), and other colleagues to support key process/system improvements.
• As a valuable member of the SQM team, participate in enhancing International RA, Global RA and CRQA's Annual Quality Plans, Quality Management Reviews, Audit & Inspection readiness (AIR), Active Risk Management, and other quality governance mechanisms, ensuring continuous improvement.
• You will be conducting Change Control Review Boards (CCRBs) with all countries and functions in scope ensuring the Change Control Process is followed and maintaining oversight on the ongoing changes at the affiliates.

You will be responsible for:
 

As as member of the SQM Team supporting all International Ra, Global RA and CRQA teams:

• Serve as a key thought leader with a creative approach to resolving complex issues, aligning program/project efforts with the short- and long-term strategic objectives of the Business Units.
• Take the lead in establishing an Quality Culture within International RA / Global RA / CRQA, promoting best practices and building a network for continuous improvement. Collaborate with senior Quality stakeholders to ensure consistent and efficient deployment of Project Management and Operational Excellence knowledge, tools, and standards.
• Support Commercial Quality Leadership in identifying, evaluating, and addressing fundamental quality risks and issues through the creation of an annual strategic quality plan. Periodically assess and escalate top risks within the QMS, developing implementation plans, conducting risk assessments, and implementing contingency plans.
• Collaborate with cross-functional stakeholders to drive improvements in current International RA/Global RA  processes and infrastructure. Enhance efficiency, scalability, and robustness to support International RA/Global RA and CRQA QMS performance globally. Eliminate redundancies, improve knowledge management, and integrate systems for increased productivity, transparency, and quality.
• Assist Commercial Quality Leadership and Central Quality team in running and enhancing the Quality Management Review for International RA, Global RA, CRQA and Division CRQA Quality Management Review. Focus on increasing management awareness and oversight of QMS performance, including inspection and audit performance, quality systems, key International RA / Global RA / CRQA processes, quality risks, and updates to the Annual Quality Plan focus areas.
• Develop or review relevant GxP SOPs governing GMP/GDP  impacting Regulatory and Quality activities, identifying areas for improvement and addressing gaps. Ensure appropriate escalations and notifications to executive-level management for all International RA / Global RA / CRQA issues. Collaborate with International RA / Global RA / CRQA colleagues and Central Quality to identify and implement innovative GxP training needs, fostering a Quality Culture in RA and Countries/Affiliates. Facilitate Change Control Review Boards (CCRBs) and Deviation Review Boards (DRBs)
• Foster an environment of talent development and learning to support a scalable and flexible organization that is future-focused.
• Coach and Mentor other members of the Quality team.
   

You will need to have:

• 10+ years of hands-on Quality Assurance / Compliance and management experience in pharmaceutical/ biotech industry. Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance.
• Extensive knowledge in a broad range of pharmaceutical regulatory activities and Quality Systems.
• Strong Management & leadership ability
• Self-motivated, flexible, and creative leader, able to prioritize, multitask and work in a fast-paced and demanding environment
• Proven track record of stakeholder management

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.