Quality Assurance Senior Manager

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. Quality Assurance Senior Manager What you will do Let's do this. Let's change the world. In our mission to serve patients, speed is absolutely critical. We're rapidly expanding our hiring initiatives and are excited to unite with the most passionate and brilliant scientific minds who want to join our team - working toward our mission of advancing high potential programs for cancer patients around the world. The position serves as the Quality Alliance Lead and the primary Amgen Quality point of contact for coordination interactions with Amgen business partners. This position will also support Portfolio Strategy Quality responsibilities. Responsibilities include: Responsible for leadership and coordination of Quality as needed across Amgen, for interactions with business partners, Amgen sites, and corporate business units. Lead strategic negotiation, development and ongoing oversight of high-impact partnerships and alliances from a Quality perspective. Negotiate Quality Agreements and participate in the negotiation of relevant Supply agreements to ensure appropriate Quality requirements are defined. Participate in regulatory inspections as necessary relating to partnerships/alliances to ensure successful business outcomes. Coordinate and facilitate partner visits by business partner Quality representatives. Coordinate specific activities relating to audits of Amgen by business partners. Lead and manage partner Quality forums and Partner Annual Reviews. Collaborate with Business Development partners to ensure business priorities are successfully completed. Participate in the development of new partner strategic plans and participating in the execution of application tasks to successfully accomplish project goals. Develop strong partnership with internal manufacturing network and relevant contract manufacturing sites to ensure alignment. Quality representative in External Supply Site Selection processes, including, performing Due Diligence visits, participating and delivering Site Selections as Quality representative, qualifying suppliers by performing Quality audit, authoring and negotiating Quality Agreements, and authoring Periodic Monitoring Reports; works in collaboration with External Supply Quality function that oversees CMO/CTL. Liaise with peers within the Quality organization to ensure continued evolution of Amgen's Quality system are aligned with developing partnership and alliance needs. Responsible for the execution of projects necessary to achieve corporate and departmental goals. Ability to conduct and act upon thoughtful risk analysis. Knowledge of continuous improvement principles and experience in implementing continuous improvement efforts across a global team. Establish standard processes for completion of key tasks and drive continuous improvement activities. Travel both domestically and internationally about 15% Remote work option may also be considered 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 an individual with these qualifications. Basic Qualifications: Doctorate degree 2 years of Quality experience OR Master's degree and 6 years of Quality experience OR Bachelor's degree and 8 years of Quality experience OR Associate's degree and 10 years of Quality experience OR High school diploma / GED and 12 years of Quality experience In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above Preferred Qualifications: 7-10 years' experience (Manufacturing, Process Development, or Quality Assurance) in the pharmaceutical/biotech industry Experience involving the development of Quality Agreements and relationships with globally diverse partners Work in a team matrix environment and independently interact with various levels of management Direct experience with bulk manufacturing of biopharmaceuticals Demonstrated proficiency leading negotiations Excellent communication skills, both written and oral, Knowledge of Quality Assurance functions and practices Ability to evaluate and lead negotiations around Quality Agreements Experience in project management (managing projects, defining scope, tracking achievements) Ability to effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes Appropriate cultural awareness and ability to work effectively with those from other cultures/countries 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, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. 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. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.