Amgen

Director, Quality North America

Employer
Amgen
Location
Thousand Oaks, CA
Posted
Jun 05, 2021
Ref
R-120216
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Contract

Job Summary

This role will oversee aregional team of quality professionals with responsibilityfor quality oversight of external suppliers which provide global goods andGxPmanufacturing, testing, storage & distributionservices to Amgen. This includesClinical & CommercialContract Manufacturing Organizations (CMOs), contracttestlabs(CTLs)that provideregulatedtesting, device manufacturersand material suppliers that provideproduct contactmaterials& componentsto 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 safetyand compliance.Works closely withcounterpartsin External Supply, Process Development, and various other parts of Operations to drivemeaningful change and outcomes for Amgen and patients around the world.Providescleardirection 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 ofstrategy for measuring and continually monitoringhealth of the quality systemsat global external suppliers, CTLs andCMOs

  • Determinesremediationactions and ensuresqualified staffareassigned toexecute

  • Focuses operational resourcesandleads the design of systems that enable expandingcapacity and capability to meet increasing complexity, agilityandsupplydemands

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

  • Leadstheinterpretationand drives the implementationofExternal Supply impactingGxPrequirements,which enableacompetitive advantage forAmgen

  • Establishes and maintains keyqualityperformance indicators (KPIs) for suppliers within area ofresponsibility

  • Sets project timelines and priorities for key initiatives and/or teamactivities

  • Providesexpert input into quality issues associated with ongoing operations, projects, andprograms

  • Demonstrates deep knowledge of manufacturing and testing requirements in an evolving regulatoryenvironment

  • Leads and develops aglobalteam, providing staff member supervision and on-going coaching; to include leading remoteteams

  • Ensures areas of responsibility are staffed, organized, and resourced to ensureGxPobligations arefulfilled

  • Drives Operational Excellence and champions changewithin and across stakeholder and partner functionalgroups

  • Holds self and team fully accountable for delivering Organizational goals and Objectives within area ofresponsibility

  • Leads an Inspection Readiness program to ensureyourCMOs and Suppliers are successful in theirinspectionoutcomes and closeout of observations/commitments ontime

Basic Qualifications

Doctorate degree and4years ofQualityexperience

OR

Masters degree and8years ofQualityexperience

OR

Bachelors degree and 10years ofQualityexperience

AND

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

Preferred Qualificationsand 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 multiplesources

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

  • Ability to operate in a matrixed or team environment with site, functional, and executiveleadership

  • Experience drivingflexible thinking anddecision makingusing DAIprinciples

  • 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 timelinesandoversee multiple projectssimultaneously

  • Strong problem solving, trouble shooting, and communicationskills

  • Demonstrated leadership in various qualityfunctions

  • Demonstrated ability to remain calm under duress or in stressfulsituations

  • Ability to understand details,and alsoflex to understand and communicate strategicintent

  • Ability to articulate issues in a way that is easily understood by executiveleadership

  • Demonstrated ability to develop high performing teams and growth of future Amgenleaders

  • Makes risk-based decisions based on Amgen First and decision-making processes that reflect Quality beyondcompliance

  • Displays a continuous improvement attitude byconstantly and directlychallenging status quowithin team andwithpeers

  • Experience leading diverseteams

  • Ability to travel20% of time to domestic and international Amgensites

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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, or disability status.


Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.