Specialist Supply Chain Compliance

Career Category Supply Chain Job Description Join 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. Specialist Supply Chain Compliance What you will do Let’s do this. Let’s change the world. In this vital role you will require a strong ability to collaborate cross-functionally with other Amgen business units. Operational Responsibilities Own and manage deviations, trend investigations records, CAPA and CAPA EV records. Lead root cause analysis sessions. Own and manage the trend trigger and periodic evaluation report for temperature excursions and distribution complaints. Provides training sessions related to SC Compliance. Act as Subject Matter Expert (SME) for the Quality Systems Deviation, CAPA, CAPA EV, Temperature excursion, Distribution Complaint and Periodic monitoring. Participate in and support inspection readiness activities, audits and inspections. Deploy new (global) capabilities and projects as appropriate. Supports change management and operational excellence initiatives to improve process compliance performance. Author and Own documents (procedures, forms, manuals, training materials etc.) for the SC Compliance team. Lead Event Review meetings for missing product events. Perform data analysis for Management reviews of the quality system on a periodic basis. Incidentally own and manage temperature excursion records of products. Provide guidance/ direction in all areas of GDP and FMD. Management Responsibilities Responsible for hiring, training, supervising, coaching and performance management of SC Compliance staff. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a self-starter with these qualifications. Basic Qualifications: Doctorate degree OR Master’s degree and 2 years of Supply Chain experience OR Bachelor’s degree and 4 years of Supply Chain experience OR Associate’s degree and 8 years of Supply Chain experience Or High school diploma / GED and 10 years of Supply Chain experience Preferred Qualifications: Experience in audit / inspection support Technical writing skills What you can expect of us As 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. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. 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. . Salary Range 107,333.00 USD - 137,857.00 USD 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 biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen