Senior Manager, Internal Quality Compliance

at  Alexion PharmaceuticalsInc

THIS IS WHAT YOU WILL DO:

The Senior Manager, Internal Quality Compliance forms a key part of the Central Quality Systems & Compliance (CQSC) function and has key responsibilities in leading the global GMP, GDP, Pharmacopeial and medical device quality regulatory compliance intelligence program,supporting health authority inspection and internal audit programs.
This includes monitoring and delivery of the global landscape for regulatory changes, communicating changes to relavent key stakeholders by providing insights and data, and leading the knowledge management within Aleixon for these changes. The role is responsible for assignment to the business and follow-up to closure of all tasks.
The incumbent will be responsible for supporting the Alexion audit and health authority inspection function manage the end to end process for audits and inspections, including preparation, conduct and supporting the response commitment process, ensuring best practices are implemented and employees fully educated in the audit/inspection management system and processes.

YOU WILL BE RESPONSIBLE FOR:

• Monitor the global GMP, GDP, Pharmacopeial and Medical Devices regulatory environment with the goal of anticipating and communicating regulatory trends through an understanding of regulatory guidelines, regulations and laws that may have an impact on Alexion’s products and regulatory business processes.
• Communicate clearly and effectively (verbally and written) the changing regulatory landscape and impact on developments to a broad, diverse and global audience
• Building and maintaining strong customer relationships with other functions whose activities overlap, influence or affect compliance and lead or participate with other Alexion/AZ quality and intelligence groups groups.
• Alexion business owner of the Regulatory Intelligence tools and systems (i.e., Clarita, Cortellis, BSI Navigator), and optimize collection, curation, communication, documentating and archiving of intelligence.
• Develop strong internal networks with other AstraZeneca Intelligence groups and cross-functional partners, and work closely with them to identify, integrate, and disseminate relevant, targeted Regulatory insights/learnings.
• Represent Alexion on Pharmacopial compliance activities
• Maintaining up-to-date global audit, inspection schedules;regualtory intelligence newsletters and generating periodic metric reports suitable for viewing by and presentation to Senior Management/leadership.Support the lifecycle of the health authority inspection readiness program through effective project and task management, by hosting meetings, utilizing effective communication skills and influencing and supporting cross-functional teams.
• Support compliance risk identification, mitigation, escalation and reporting, arising from audits, inspections and the regulatory landscape.
• Driving, role modeling and supporting a strong lean culture that promotes standardization, simplification and continuous improvement. Participate and lead compliance improvement projects within CQSC.
• Support the management of 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.
• Up to 20% travel maybe required.