Senior Associate QA, Global Distribution Quality (GDQ)

Career CategoryQualityJob DescriptionJoin Amgen’s Mission of Serving PatientsAt 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.Senior Associate QA, Global Distribution Quality (GDQ)What you will doWe are seeking a highly motivated individual for our Global Distribution Quality (GDQ) team. This is an incredibly exciting opportunity to join a team of quality professionals in global distribution team. The Sr. Associate QA position will implement and oversee global product distribution and transportation from Amgen’s Global Supply Hubs to Amgen’s global markets, and provide QA oversight of QA activities for Global Supply Chain operations.Working 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, as well as QA triage of Distribution complaints.Work closely with all relevant partners for the end-to-end process and ensure compliance to GMP/GDP.Act as subject matter expert (SME) for transportation related Quality ProcessesCollaborate with the 3rd Parties to ensure alignment to service levels, identifying and implementing performance improvementPrepare, 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 regulationsUnderstand and incorporate risk management strategy into overall supply chain strategyProvide support for logistic service provider and transportation service provider oversightSupport in tactical activities for internal/external audits and inspections as part of the audit/inspection teamProvide quality expertise and guidance to operational staff and within multi-functional Amgen teamsTake 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 relationships.Work under minimal supervision in line with Amgen Values and Leadership AttributesWhat we expect of youBasic Qualifications and ExperienceWe 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 fields.Understanding of GMP/GDP requirements.Familiarity with logistics processes of parcel, transport, and warehousing providers.Experience in Validation/Qualification of processes, equipment, and facilities.Deep technical writing skills.Independent self-starter, able to work autonomously, under pressure and in teams.GMP/GDP knowledge and understanding of pharmaceutical regulations.Energetic, detail oriented, highly motivated with a “can do” outlook.Change management skills.Ability to communicate across all levels of the organization.Effective written and verbal communication skills.Experience with Microsoft Office Tools including Excel, Word, and PowerPoint.Ability 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.careers.amgen.comAs 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..