Director, Quality Audit, Inspections and Regulatory Compliance

This is what you will do:

The Director of Quality Audit, Inspections, and Regulatory Compliance is a key leadership role responsible for:

• Developing and implementing a strategy for audits and inspections across Alexion’s Global Operations and Marketing Companies’ range of products, processes and suppliers.
• Providing up-to-date and relevant information for audit planning, conduct and execution through participation with external industry organizations, application of trends and gaps identified through audits, and assessment of trends identified through the Quality Management System (QMS).
• Ensuring that Alexion’s Global Operations and Marketing Companies are informed of and compliant with global regulatory requirements by monitoring all planned regulatory updates in relevant markets.
• Determining and managing workload and resources for the Audit, Inspection and Regulatory Compliance team.

You will be responsible for:

• Identifies and oversees the design and implementation of relevant Audit, Inspection and Regulatory Compliance processes and procedures, including metrics, thresholds, and continuous improvement initiatives.
• Sets the overall Alexion global operations audit strategy (GDP and GMP) and approves annual audit plans, engaging senior leadership as necessary to ensure their execution throughout the year.
• Approves audit reports and responses, assuring completeness, accuracy and clarity of findings and resulting corrective and preventative actions.
• Partners with Quality Oversight Leads to understand business needs and communicate audit results, program trends and regulatory compliance updates.
• Provides leadership and management of the Global Operations Audit, Inspection and Regulatory Compliance team managing workload and team performance.
• Oversees Alexion Global Operations and Marketing Company regulatory inspection readiness activities and ensures harmonized readiness approaches and communications across all GxPs.

May support sponsor regulatory inspections, either as an SME of the audit program or fulfilling a front/back-room role. Informed of all inspections activities & outcomes and may coordinate/provide input to inspection responses impacting the organization

You will need to have:

• A university degree is required. Preference will be given to those with degrees in a relevant field.
• Minimum of 5 years’ people management experience.
• 10 to 15 years of recent experience in pharmaceutical/ biotech industry with thorough knowledge of applicable global regulatory and GxP requirements.
• Ability to influence and lead through others and develop trusted working relationships with colleagues internal to Quality and across the organization.
• Excellent communication skills and ability to expertly manage stakeholders at all levels of the organization.

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.