Career Category

Job Description

Job Summary 

This role will oversee a regional team of quality professionals with responsibility for quality oversight of external suppliers which provide global goods and GxP manufacturing, testing, storage & distribution services to Amgen. This includes Clinical & Commercial Contract Manufacturing Organizations (CMOs), contract test labs (CTLs) that provide regulated testing, device manufacturers and material suppliers that provide product contact materials & components to Amgen sites & CMOs. Part of a multifunctional team and works within the Quality organization to ensure appropriate scientific, regulatory, and quality standards are followed to assure product quality, patient safety and compliance. Works closely with counterparts in External Supply, Process Development, and various other parts of Operations to drive meaningful change and outcomes for Amgen and patients around the world. Provides clear direction and is responsible for fostering a culture of quality and continuous improvement. Reports to the Executive Director, External Supply Quality. 

Key Responsibilities: 

·        Sets and oversees execution of strategy for measuring and continually monitoring health of the quality systems at global external suppliers, CTLs and CMOs 

·        Determines remediation actions and ensures qualified staff are assigned to execute 

·        Focuses operational resources and leads the design of systems that enable expanding capacity and capability to meet increasing complexity, agility and supply demands 

·        Provides quality oversight and guidance in best practices for proactively selecting external suppliers which provide high quality goods and services 

·        Leads the interpretation and drives the implementation of External Supply impacting GxP requirements, which enable a competitive advantage for Amgen 

·        Establishes and maintains key quality performance indicators (KPIs) for suppliers within area of responsibility 

·        Sets project timelines and priorities for key initiatives and/or team activities 

·        Provides expert input into quality issues associated with ongoing operations, projects, and programs 

·        Demonstrates deep knowledge of manufacturing and testing requirements in an evolving regulatory environment 

·        Leads and develops a global team, providing staff member supervision and on-going coaching; to include leading remote teams 

·        Ensures areas of responsibility are staffed, organized, and resourced to ensure GxP obligations are fulfilled 

·        Drives Operational Excellence and champions change within and across stakeholder and partner functional groups 

·        Holds self and team fully accountable for delivering Organizational goals and Objectives within area of responsibility 

·        Leads an Inspection Readiness program to ensure your CMOs and Suppliers are successful in their inspection outcomes and closeout of observations/commitments on time 

Basic Qualifications  

Doctorate degree and 4 years of Quality experience 

OR 

Master’s degree and 8 years of Quality experience  

OR 

Bachelor’s degree and 10 years of Quality experience 

AND 

4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources 

Preferred Qualifications and Demonstrated Skills 

·        10+ years of experience within the pharmaceutical/biotechnology industry 

·        Deep and broad understanding of Quality including batch release, complaints, change control, risk management, etc. 

·        Ability to negotiate a strategic position after taking feedback from multiple sources 

·        Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results.  Collaborates and communicates well with others 

·        Ability to operate in a matrixed or team environment with site, functional, and executive leadership 

·        Experience driving flexible thinking and decision making using DAI principles 

·        Understanding of both Amgen QMS and industry requirements/expectations of a QMS and device regulations 

·        Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) 

·        Able to manage workload to timelines and oversee multiple projects simultaneously 

·        Strong problem solving, trouble shooting, and communication skills 

·        Demonstrated leadership in various quality functions  

·        Demonstrated ability to remain calm under duress or in stressful situations 

·        Ability to understand details, and also flex to understand and communicate strategic intent 

·        Ability to articulate issues in a way that is easily understood by executive leadership 

·        Demonstrated ability to develop high performing teams and growth of future Amgen leaders 

·        Makes risk-based decisions based on Amgen First and decision-making processes that reflect Quality beyond compliance 

·        Displays a continuous improvement attitude by constantly and directly challenging status quo within team and with peers 

·        Experience leading diverse teams 

·        Ability to travel 20% of time to domestic and international Amgen sites