Sr Associate Supplier Quality

Career CategoryQualityJob DescriptionJoin 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. 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.Sr Associate Supplier QualityWhat you will doThe Sr Associate Supplier Quality position is responsible for the Quality and Compliance Oversight of Raw material suppliers. This position is responsible for being an integral quality member of the Amgen multi-functional raw materials suppliers' team that includes but is not limited to business operations, analytical science, process development, and supply chain.Role DescriptionWorking independently, the individual will be responsible for, but not limited to the following:Perform QA Contact role on the Quality Events, Change Control records, Corrective and Preventive Actions, effectiveness verification and documentationWork closely with all relevant stakeholders for the end-to-end process and ensure compliance to GMP/GDPPrepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulationsCollaborate with raw material suppliers to ensure alignment to quality agreements, identifying performance improvement opportunitiesUnderstand and incorporate risk management strategy into the overall raw material lifecycleProvide support to the supplier periodic monitoring oversight activitiesSupport in tactical activities related to internal/external audits and inspectionsPerform routine quality assessments and provide approval of changes to raw material inspection profilesTake part in operational improvement initiatives, programs, and projectsDevelop solutions that are thorough, practical, and consistent with functional objectivesOwnership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationshipsWork under minimal supervision in line with Amgen Values and Leadership AttributesWhat we expect of youEducation and Experiences:We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is a strong leader with these qualifications:Bachelor's degree in science or engineering and 2+ years of professional experience in related fieldsUnderstanding of GMP/GDP requirementsFamiliarity with raw material compendial testingExperience overseeing quality of suppliers or external partiesDeep technical writing skillsPreferred QualificationsStrong continuous improvement approach and lean practices experienceUnderstanding of end-to-end supply chain business processesExperience in project management across multiple departments and geographiesQuick process understanding, insight and visualizingStrong analytical and problem-solving skillsIndependent self-starter, able to work autonomously, under pressure and in teamsGMP/GDP knowledge and understanding of pharmaceutical regulationsEnergetic, detail oriented, highly motivated with a "can do" outlookChange management skillsAbility to communicate across all levels of the organizationEffective written and verbal communication skillsExperience with Microsoft Office Tools including Excel, Word, and PowerPointAbility to multi-task and prioritizeWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.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..