Manager Manufacturing Environmental and Contamination Control

Location: West Greenwich

** Join Amgen's Mission of Serving Patients*
* At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's 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, you'll 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, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

** Manager Manufacturing Environmental & Contamination Control*
* ** What you will do*
* Let's do this. Let's change the world. 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*
* The Front-Line Manager

** Direct Management of Deviation Owners & FAO's*
* + Lead and coordinate:

+ Deviation Owners (execution)

+ 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 → 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)

+ 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

+ Classification reflects risk (not bias or precedent)

** Decision Facilitation & Alignment*
* + Facilitate alignment between:

+ FAO

+ QA

+ Deviation Owner

+ Ensure decisions (classification, disposition) are clearly documented

** CAPA Execution & Follow-Through*
* + Ensure CAPAs are:

+ Assigned

+ Owned

+ 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

+ 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

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

** 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

+ Bachelor's degree and 5 years of manufacturing or operations experience OR

+ Master's 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…