OverviewQuality Compliance Senior Manager at Amgen. This role is within Regulatory Compliance, supporting Inspections Lifecycle Management (ILM) at the Amgen Dún Laoghaire site. Leads preparation for, execution of, and response to Regulatory Agency and Business Partner inspections; collaborates cross-functionally to maintain inspection readiness; and develops formal response commitments and improvement actions.What You Will DoPrepare for inspections through cross-functional and cross-site collaboration with strong on-site presence to ensure perpetual inspection readiness for the ADL site.Execute inspections, including direct interaction with inspectors and support in required functions.Lead the generation of formal response commitments for the ADL site and cascade inspection outcomes across Amgen sites and functions.Identify improvement opportunities and track commitments and actions to completion.Establish and maintain best practice inspection lifecycle processes from preparation through inspection outcomes, to be applied consistently across Amgen globally.Apply knowledge of current regulations, standards, and guidelines, in addition to SOP requirements, to support inspections.May serve as a Subject Matter Expert (SME) for GMP/GDP topics in support of the Quality Management System, self-inspections, and regulatory documentation related to ADL site inspections/certification.What We Expect Of YouWe seek a leader with the following qualifications.Basic QualificationsHigh school diploma / GED with 12 years of Quality Compliance experience ORAssociate’s degree with 10 years of Quality Compliance experience ORBachelor’s degree with 6 years of Quality Compliance experience ORMaster’s degree with 4 years of Quality Compliance experience ORDoctorate degree with 2 years of Quality Compliance experiencePreferred QualificationsBachelor’s Degree in Life Sciences or EngineeringExperience leading or participating in roles to prepare for, execute, and respond to Health Authority inspectionsExperience auditing and defending processes during Health Authority inspections7+ years in pharmaceutical manufacturing, process development, or quality assurance with increasing responsibility and proven experience in compliance, data analysis, project management, and quality systemsExperience managing staff and leading cross-functional teams or programsSolid understanding of quality management systems and quality control for bulk drug, drug/combination product, and finished productsExposure to bulk drug and drug/combination and finished product manufacturing and QA processesExperience with facility start-ups and expansionsSolid understanding of EU and US cGMPs and GDPsAbility to work autonomously, present data clearly, and communicate effectivelyExperience with process improvement projectsStructured problem-solving ability to navigate ambiguityTrack record of building or participating in impactful teamsAbility to coordinate and lead cross-functional project teams to meet expectations and timelinesAbility to maintain remote working relationships with teams at other Amgen sites to align to standard methodologiesWhat You Can Expect From UsAmgen supports teammates’ professional and personal growth and well-being. In addition to base salary, Amgen offers competitive Total Rewards Plans aligned with local industry standards.How to ApplyApply now for a career that defies imagination with Amgen.Location: Dublin, County Dublin, Ireland and surrounding areas
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