Career CategoryQualityJob DescriptionABOUT AMGENAmgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.ABOUT THE ROLERole Description:This role is an individual contributor role that provides critical support to Product Quality Teams (PQTs) for late-stage clinical and commercial products. In this role, you will serve as a primary author of technical and regulatory reports, manage GMP data within compliant systems, and help ensure accuracy, completeness, and compliance across global submissions.You will also play an integral role in maintaining Amgen’s electronic databases and mapping tools, supporting continuous improvement initiatives, and providing peer training as needed. This role requires strong expertise in GMP compliance, technical writing, and cross-functional collaboration to drive high-quality outcomes under tight timelines.Roles & Responsibilities:Navigate and execute transactions in GMP systems (Empower, LIMS, Veeva, Spotfire).Work closely with in the product Quality organization to drive standardization of data, and chromatographic overlay activities.Author and maintain GMP technical reports supporting regulatory filings within quality systems (e.g., Veeva).Collate, review, verify, and archive GMP data for late-stage clinical and commercial products.Ensure accuracy and completeness of product data with high attention to detail.Collaborate across global teams and time zones, effectively communicating findings and project updates.Basic Qualifications Master’s degree with minimum 6 years of Pharmaceutical/Biotechnology experience in Quality, Operations, Scientific, or Manufacturing fieldsFunctional Skills:Must-Have Skills:Strong understanding of GMP requirements, US FDA, and ICH regulationsProven technical expertise in Chromatographic techniques /software and overlaysExpertise in GMP systems (Veeva, Empower, LIMS, Spotfire)Strong data management, analytical, and problem-solving skillsExperience supporting cross-functional teams in matrixed, global environmentsProficiency in MS Office (Word, Excel, PowerPoint, Teams)Excellent written and verbal communication across all levels of the organizationContinuous improvement mindset with experience applying lean practicesGood-to-Have Skills:Knowledge of stability data management and annual product reviewExperience in assembling annual product reviewsExperience in business process improvement and electronic data tool developmentSoft Skills:Strong initiative and self-motivationTeam-oriented mindset with focus on achieving shared goalsAbility to work effectively in diverse, global, virtual environments with minimal supervisionWhat Success Looks LikeTimely and accurate delivery of technical and regulatory reportsEffective collaboration across global teams to meet project milestonesProactive improvements to data management processes and quality systemsContribution to team knowledge through peer training and mentorshipGrowth & DevelopmentThis role offers opportunities to build advanced expertise in GMP compliance, regulatory authorship, and quality systems.EQUAL OPPORTUNITY STATEMENTAmgen is an Equal Opportunity employer. We will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.We are committed to providing reasonable accommodation for individuals with disabilities during the application and interview process, in performing essential job functions, and in accessing employment benefits. Please contact us to request accommodation..