[02/11/2025] Manager, R&d Process Quality

Career Category Quality 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 MANAGER R D PROCESS QUALITY What you will do Let s do this Let s change the world In this vital role you will work with a team of process-focused colleagues who work to implement Amgen s Process Quality strategy which is vital to ensuring that Amgen s Research and Development Standards SOPs and associated documentation are adequate clear and up to all applicable current regulations and quality requirements The R D Process Quality team supports the Quality Management System QMS across all areas of research at Amgen including discovery through the full clinical development lifecycle This team ensures that all Amgen business procedures meet internal and external quality standards and are managed for optimum efficiency and effectiveness The Process Quality team also ensures that Amgen s R D Business Process Network develops and manages fit for purpose standards SOPs that are continuously improved upon using quality by design QbD and risk management methods that include QMS analytics showing quality signals and trends Responsibilities Supports Amgen s procedural framework so that all procedures maintain compliance to relevant laws regulations and internal quality standards works to ensure that procedures maintain the ethical and safe treatment of all research subjects and that all data has integrity Ensures that all procedures are written clearly for the execution of Amgen s research tasks within a diverse complex and cross-functional team of researchers Supports the change control of business procedures in a timely manner with a focus on detail and the output of concisely written documentation Supports incoming procedural change requests including the assessment of changes impact to the QMS including traceability of changes across other document sets Supports the work of Business Process Owners and applies risk-based strategies consistently to identify and mitigate risks towards the continuous advancement of Amgen s R D QMS Applies industry standard processes for optimal standardized and lean procedural documentation and the use of technology to drive an efficient and effective knowledge management system Supports the application of process metrics KQI KPI - leading and lagging and modern analytic methods across the Business Process Network in order to enable Management Reviews periodic review by management to ensure QMS health is maintained Collaborates with other quality professionals within R D to support the QMS continuous improvement cycle Plan Do Check Act including Deviation Management Corrective and Preventative Actions CAPA What we expect of you We are all different yet we all use our unique contributions to serve patients The individual we seek has technological literacy and leadership skills and has these qualifications Basic Qualifications Doctorate degree OR Master s degree and 3 years of quality experience OR Bachelor s degree and 5 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 AND In addition to meeting at least one of the above requirements you must have 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 Experience within Biotech pharmaceutical Research including the application of Global Regulations Direct experience working with standard procedural documentation including their creation change control requests for change and the execution of changes Solid understanding of SOP Standards management and methods technology used to drive knowledge management across a diverse R D environment Strong Process Mind and analytically oriented - experience with process monitoring including the application of analytical methods and modern technology used to enable signal detection and quality improvement Proven team player - takes direction and is able to rapidly learn and support a hard-working team and is able to make rapid decisions and communicate them in a timely manner Excellent verbal and written communication skills - demonstrates strong business writing abilities and active listening Capability to understand and articulate technical concepts and literature in spoken and written English What you can expect from 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 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 Amgen is an Equal Opportunity employer and will consider you without regard to your race color religion sex sexual orientation gender identity national origin protected veteran status or disability status