HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

BASIC QUALIFICATIONS:

• High school diploma / GED and 12 years of Quality Compliance experience OR
• Associate’s degree and 10 years of Quality Compliance experience OR
• Bachelor’s degree and 6 years of Quality Compliance experience OR
• Master’s degree and 4 years of Quality Compliance experience OR
• Doctorate degree and 2 years of Quality Compliance experience

PREFERRED QUALIFICATIONS:

• Bachelor’s Degree in Life Sciences or Engineering
• Experience with leading and/or participating in key roles to prepare for, execute and/or respond to outcomes from Health Authority inspections
• Experience in auditing and defending processes, procedures and decisions during Health Authority inspections
• 7+ years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical industry with progressively increasing responsibility and proven experience in compliance, data analysis, project management, and quality systems
• Experience managing staff and/or leading cross-functional teams, projects and/or programs
• Thorough understanding of quality management systems and quality control processes related to bulk drug, drug/combination product and finished product for clinical and commercial operations
• Previous exposure to bulk drug and drug/combination and finished product manufacturing and quality assurance processes
• Experience with facility start ups and/or expansions
• Detailed solid understanding of EU and US Good Manufacturing Practices (cGMPs and GDPs)
• Proficiency in ability to work autonomously, present data in an organized and logical manner and an ability to communicate effectively.
• Experience with process improvement projects
• Proficiency in navigating through ambiguity and provide a structured problem-solving approach
• Track record of building or participating as a member of impactful teams
• Proficiency in coordinating and leading cross-functional project teams to deliver to expectations and on schedule
• Ability to maintain remote working relationships with team mates at other Amgen sites in order to identify and align to standard methodologies

Let’s do this. Let’s change the world. In this vital role within the Regulatory Compliance function as the Senior Manager of Inspection Lifecycle Management (ILM), you will be involved in the preparation for, execution of and response to Regulatory Agency and Business Partner inspections at the Amgen Dún Laoghaire (ADL) site.
Preparation includes cross-functional and cross-site collaboration along with a strong on site presence for assuring a perpetual state of inspection readiness for ADL. Execution of the inspections includes serving in roles with direct interaction with inspectors as well as serving in support rooms/functions as needed. The role also includes leading the generation of formal response commitments for the ADL site, cascading inspection outcome information across Amgen sites and functions, identifying improvement opportunities and tracking commitment and improvement actions to completion.
Being a part of the ILM team includes being responsible for establishing and maintaining best practice and effective inspection lifecycle processes from preparation/readiness through execution and inspection outcome processes, so they can be applied consistently across Amgen globally. The position will apply knowledge of current regulations, standards and guidelines, in addition to requirements of applicable Standard Operating Procedures (SOP’s), in the support of inspections.

In addition, the position may entail serving as a Subject Matter Expert (SME) for GMP/GDP compliance topics in support of various aspects of the Quality Management System (QMS), supporting Amgen’s self-inspection program as well as being responsible for fulfilling various regulatory requests and documentation related to ADL site inspection/certification status.

• Collaborate with functional areas and across Amgen in preparation for inspections
• Perform site inspection readiness efforts including strategy sessions and pressure tests
• Participate in inspections that may require direct/indirect interaction with regulators
• Lead response and improvement actions resulting from Regulatory Agency and/or Business Partner inspections
• Lead maintenance and continuous improvement for at least one (1) inspection lifecycle process stage and support all others
• Represent site and Regulatory Compliance function on global networks
• Provide clients with guidance on regulatory compliance expectations and trends
• Provide leadership toward resolving site and multi-site compliance risks
• Provide support to Regulatory submission teams
• Support self inspection (internal audits) program
• Perform tasks and participate on project teams as assigned to complete site, departmental, team and goals of the company.