Amgen
Sr. Manager, Clinical Quality Therapeutic Area
Amgen, Newbury Park, California, United States, 91320
Senior Manager, Clinical Quality Therapeutic Area
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 missionto serve patients living with serious illnessesdrives 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. In this vital role you will be a team member on one of the Therapeutic Area (TA) Quality teams, which include Oncology, General Medicine, Rare Disease, and Inflammation/ Biosimilars, and you will report to one of the TA Quality Leads within Clinical & Research Quality (CRQ). As a Senior Manager you will provide proactive, end to end quality oversight through various methods of risk-based quality management activities, including quality by design and real-time analysis of quality data/metrics. In this important role, you will develop deep knowledge of the TA's clinical trials and provide oversight and quality management of critical data and processes for global and local study teams and all clinical trial sites who participate in Amgen sponsored trials. In addition, you will support the management of quality and compliance for specific regions, including clinical trial sites and vendors who work within those regions. The TA Responsibilities Review clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes Provide quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to ensure the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare and rights Provide oversight for the development and implementation of Quality Plans Establish Regional expertise to ensure quality and compliance to local regulations Support TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarker usage and imaging methods) Develop TA-specific Quality Assurance plans that are risk based and efficient. This includes TA specific audit plans, and the execution of audits (investigator site audits, affiliate audits, and study level audits). Support Clinical Trial Teams for all quality management activities, including Deviations/CAPAs, Inspection Readiness activities, and Inspection Management, and Serious Breaches/ Privacy Issues Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods leveraging AI and Natural Language Processing, and other advanced data analytics methods). 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. Doctorate degree and 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 5 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility. Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise. Thorough understanding of Clinical R&D activities and Global Regulations. Knowledge of the Regulatory Submission and Inspection Management procedures. Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions. People leadership and managerial expertise. Excellent verbal and written communication skills, including strong business writing abilities and active listening. Ability to transform business and customer feedback into clear, efficient processes using a straightforward language and format. Strong analytical, critical-thinking, and decision-making abilities. Capability to understand and articulate technical concepts and literature in spoken and written English. 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.
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 missionto serve patients living with serious illnessesdrives 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. In this vital role you will be a team member on one of the Therapeutic Area (TA) Quality teams, which include Oncology, General Medicine, Rare Disease, and Inflammation/ Biosimilars, and you will report to one of the TA Quality Leads within Clinical & Research Quality (CRQ). As a Senior Manager you will provide proactive, end to end quality oversight through various methods of risk-based quality management activities, including quality by design and real-time analysis of quality data/metrics. In this important role, you will develop deep knowledge of the TA's clinical trials and provide oversight and quality management of critical data and processes for global and local study teams and all clinical trial sites who participate in Amgen sponsored trials. In addition, you will support the management of quality and compliance for specific regions, including clinical trial sites and vendors who work within those regions. The TA Responsibilities Review clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes Provide quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to ensure the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare and rights Provide oversight for the development and implementation of Quality Plans Establish Regional expertise to ensure quality and compliance to local regulations Support TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarker usage and imaging methods) Develop TA-specific Quality Assurance plans that are risk based and efficient. This includes TA specific audit plans, and the execution of audits (investigator site audits, affiliate audits, and study level audits). Support Clinical Trial Teams for all quality management activities, including Deviations/CAPAs, Inspection Readiness activities, and Inspection Management, and Serious Breaches/ Privacy Issues Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods leveraging AI and Natural Language Processing, and other advanced data analytics methods). 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. Doctorate degree and 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 5 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility. Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise. Thorough understanding of Clinical R&D activities and Global Regulations. Knowledge of the Regulatory Submission and Inspection Management procedures. Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions. People leadership and managerial expertise. Excellent verbal and written communication skills, including strong business writing abilities and active listening. Ability to transform business and customer feedback into clear, efficient processes using a straightforward language and format. Strong analytical, critical-thinking, and decision-making abilities. Capability to understand and articulate technical concepts and literature in spoken and written English. 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.