This is what you will do: The Associate Director, Quality Compliance, is a member of the Alexion RDU Central Quality Systems & Compliance (CQSC) team. The Associate Director has key responsibilities in managing the Alexion GMP, GDP and Medical Devices internal audit, Inspection readiness and Regulatory Compliance Intelligence programs.
The incumbent will be responsible for the design and execution of the Alexion RDU GMP and GDP self-inspection/internal audit program. They will support the organisation with respect to Health Authority Inspections from planning to reporting to closure, ensuring best practices are implemented. They will ensure that Alexion RDU GMP and GDP partners are aware of relevant regulatory updates and outcomes and monitor compliance to same.
You will be responsible for: Lead the end to end process for management of internal Audits, Health Authority Inspections and Regulatory Intelligence at Alexion to drive compliance across the business.Conduct independent appraisals of quality and compliance systems within technically advanced manufacturing, distribution and testing settings.Initiating and maintaining close contacts with regulatory agencies and/or industry/professional organizations to keep aware of trends and initiatives in quality assurance, GMP/GDP compliance, regulations and inspections.Working closely with other QA colleagues to assure common understanding of developing interpretations of cGMP.Building and maintaining strong customer relationships with other functions whose activities overlap, influence or affect compliance and lead or participate in GxP audits/initiatives with other Alexion quality groups.Driving, role modeling and supporting a strong lean culture that promotes standardization, simplification and continuous improvement.Providing leadership and management to the team, cascading messages and goals from senior management, managing and prioritizing team workload, and managing team performance.Maintaining an up-to-date global audit, inspection schedules and regulatory intelligence newsletters and generating periodic metric reports suitable for viewing by and presentation to Senior Management/leadership.Contributing to the further development of the compliance function by shaping the Alexion compliance landscape through proposals and innovative solutions.Drive inspection readiness through effective project and task management, by hosting meetings, utilizing effective communication skills and influencing and supporting cross-functional teams.Responsible for compliance risk identification, mitigation, escalation and reporting, arising from audits, inspections and the regulatory landscape.Audit, Inspection and Regulatory action commitment creation, review, approval, and monitoring to closure.Reporting readiness status, inspection metrics to Senior Leadership.Partner with the site compliance leads, and the audit and the regulatory intelligence team to understand the internal and external compliance landscape, to implement a proactive compliance program.Participate and lead compliance improvement projects within CQSC.Implement and manage the global electronic inspection management tool and regulatory intelligence system, providing training to personnel as required. Ensure the tool/system is used consistently across the business.Monitor the global regulatory landscape for regulatory changes and trends, analyze, communicate and report to key stakeholders, in order to drive compliance to the changing landscape.Hold the repository for key regulations and standards.People management responsibilities.Up to 20% travel required.You will need to have: Bachelor's Degree required, preferably within the life science area.10+ years experience in a GMP/GDP/Medical Device related industry in a quality/compliance function is required, with strong Quality Management Systems knowledge.7+ years QA experience leading and/or conducting GxP audits.Thorough knowledge of applicable international GxP regulations and standards (e.g., GMP, GDP, Medical Device etc.).Ability to navigate and be successful in a fast-paced, cross-functional work environment.Excellent written and verbal communication skills.Strong attention to details skills, with an ability to think higher-level when required.Strong leadership skills.People management skills.Strong organizational skills.Technical writing/ reporting skills.Ability to multi-task and prioritize work.Team-oriented approach to project management and problem resolution.Ability to take on complex problems which require analysis and evaluation.The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have: Advanced Degree preferred, but not required.Experience with Quality Systems (e.g. Veeva Vault) is desirable.Experience with management of regulatory intelligence systems (e.g. Clarita, Clarivate) is desirable.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.
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