Manager Manufacturing Environmental and Contamination Control

Manager Manufacturing Environmental & Contamination Control Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What You Will Do In this vital role you will be responsible for day-to-day delivery of deviation records and investigations, ensuring Deviation Owners and FAOs execute with rigor, speed, and compliance, particularly for microbial and EM-related events. This role shall report to the Senior Manager of the Environmental and Contamination Control (ECC) team. Responsibilities Direct Management of Deviation Owners & FAO's Lead and coordinate Deviation Owners (execution) and Process Specialists (technical oversight) Ensure clear ownership assignment and appropriate planning and distribution of workload, timely movement of records Deviation Lifecycle Execution Oversee initiation triage, investigation, and closure Ensure records are complete, accurate, and audit-ready Remove barriers to timely closure and escalation Investigation Quality Oversight Ensure robust root cause analysis (RCA) and appropriate scoping and impact assessment Challenge teams to avoid superficial or convenience-based conclusions Microbial Event Execution (Critical Focus) Ensure microbial deviations receive appropriate SME engagement (QC Micro, aseptic SMEs) Verify investigations reflect true contamination risks and classification reflects risk (not bias or precedent) Decision Facilitation & Alignment Facilitate alignment between FAO, QA, and Deviation Owner Ensure decisions (classification, disposition) are clearly documented CAPA Execution & Follow-Through Ensure CAPAs are assigned, owned, and completed effectively Confirm clear linkage between root cause and actions Triage & Prioritization Lead daily deviation triage for environmental and contamination control-related events Prioritize high-risk (e.g., microbial, major deviations) Ensure effective tools and business processes are in place for tracking and reporting record progress Allocate resources appropriately Inspection Readiness Support Prepare team to speak to deviations directly and defend scientific rationale Ensure records are inspection-ready at all times Continuous Improvement Create a culture of continuous improvement among the ECC team and facilitate implementation of tools and processes that streamline the investigation process, making appropriate use of AI and other digital tools. Key Performance Metrics On-time closure (OTD) Aging backlog Investigation effectiveness CAPA cycle time Audit/inspection observations What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a collaborative leader with these qualifications. Basic Qualifications High school diploma/GED and 12 years of manufacturing or operations experience OR Associates degree and 10 years of manufacturing or operations experience OR Bachelors degree and 5 years of manufacturing or operations experience OR Masters degree and 3 years of manufacturing or operations experience OR Doctorate degree In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, prograns, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above Preferred Qualifications The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education and experience or the equivalent BS/BA or equivalent (science/engineering/psychology preferred) 8+ years of experience in the pharmaceutical industry Experience applying AI or other digital tools to generate insights and streamline workflows Strong understanding of deviation management process, root cause analysis & GMP compliance Ability to drive execution through others, manage multiple competing priorities, influence cross-functional teams & provide performance management and coaching for a team of professionals Benefits The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In Addition To The Base Salary, Amgen Offers a Total Rewards Plan, Based On Eligibility, Comprising Of Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities That May Include A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. EEO Statement As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #J-18808-Ljbffr BioSpace