Boston, MA, 02133, USA
1 day ago
GxP Learning Process, Governance, & Metrics, Sr 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. GxP Learning Process, Governance, & Metrics, Sr Manager **What you will do** Let’s do this. Let’s change the world. In this vital role you will drive the Learning process optimization and improvement across Global Quality and GxP in partnership with critical stakeholders across the matrix. This will include serving on the GxP Learning Community of Practice (CoP) and driving change across the Learning Ecosystem (Operations and R&D). The role will drive achievement and improvement of the GxP Learning processes through continuous improvement and metrics, driving transformation of the learning landscape. + Partner with cross functional leadership in developing and rolling out a culture of learning performance. + Maintain global processes, procedures, and training materials in compliance with Global GxP requirements, Amgen Global Quality Standards, and Amgen’s Quality Management System (QMS) principles. + Participate in Community of Practice (CoP), driving continuous improvement, change management, and overall learning governance. + Identify and implement solutions in partnership with the Learning CoP across the Learning Ecosystem to eliminate waste and simplify. + Drive quality growth mindset to establish a center of excellence for Quality capability building, defining standards, deployment model, in collaboration with Quality Leadership and key learning leads. + Develop capability / competency-based processes to reduce and/or replace read & understood. + Participate in benchmarking initiatives with peers externally to stay abreast of changes in regulations that affect impacted processes + Define process monitoring methods, specific to metrics and analysis across the learning ecosystem for Quality, Operations, and R&D functional areas. + Support site and functions during regulatory inspections and audits, which may include direct interface with inspectors/auditors and writing / reviewing responses. **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications. **Basic Qualifications:** Doctorate degree and 2 years of Operations and/or Development experience **Or** Master’s degree and 4 years of Operations and/or Development experience **Or** Bachelor’s degree and 6 years of Operations and/or Development experience **Or** Associate’s degree and 10 years of Operations and/or Development experience **Or** High school diploma / GED and 12 years of Operations and/or Development experience **Preferred Qualifications:** + 5 years experience in leading or working in a global function, delivering network / enterprise processes and metrics + Bachelor’s degree in Business Administration, Operations Management, Engineering, or related fields + Ability to provide innovative ideas to optimize the function and generate new ideas or alternatives that create value + Capability to build alignment with senior level business partners + Demonstrated strong ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives + Competency in executing strategic plans and directing tactical execution **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** **for a career that defies imagination** Objects in your future are closer than they appear. Join us. **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. 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.
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