Amgen
Quality Compliance Senior Manager
Amgen, Washington, District of Columbia, us, 20022
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.
Senior Manager, Quality & Compliance
What you will do In this vital role, you will report to the Therapeutic Area Quality Lead - Clinical Quality, Clinical & Research Quality (CRQ). As the Senior Manager, Quality & Compliance, you will provide proactive end-to-end quality support for developing and implementing a risk-based quality assurance strategy for the clinical development program. The R&D Process Quality team supports the Quality Management System (QMS) across all Amgen research areas, including discovery through the clinical development lifecycle. This team ensures that all Amgen's business procedures meet internal and external quality standards and are managed for optimum efficiency and effectiveness. Responsibilities Create and maintain data tools to enable stakeholders to ensure quality in the R&D space. Maintain Quality oversight related to continuous improvements (CI) associated with our QMS through metrics and key performance indicators (KPIs). Support the application of process metrics (KQI, KPI - leading and lagging) and modern analytic methods across the Business Process Network to enable Management Reviews. Ensure our CI efforts maintain a quality culture throughout the R&D and GDO organizations. Ensure that all procedures are written clearly for driving Amgen's research tasks within a diverse, complex, cross-functional team of researchers and a rapidly evolving worldwide regulatory framework. Partner with the Business Process Owner network by ensuring risk-based improvements to procedures. Apply risk methodologies to support audits across the R&D network. Apply industry standard methodologies for optimal procedural documentation and the use of technology to drive an efficient knowledge management system. Serve as a GCP Subject Matter Expert, providing independent and objective quality advice. Collaborate with other quality professionals within R&D to support the QMS continuous improvement cycle. Support a robust regulatory intelligence system. What we expect of you
The individual we seek has technological literacy and leadership skills and has these qualifications: Basic Qualifications:
Doctorate degree and 2 years of quality experience OR Masters degree and 6 years of quality experience OR Bachelors degree and 8 years of quality experience OR Associates 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, or programs. Preferred Qualifications:
7 years or more experience in quality management, quality assurance, or other relevant areas of the pharmaceutical/biotech industry. Experience in a coding language like Python or R, is preferred. Skilled translator between technical and non-technical audiences. Demonstrated ability to visualize data for consumption by business stakeholders. Experience in Tableau, is preferred. Direct experience working with standard procedural documentation. Solid understanding of SOP/Standards management. Oversight and implementation of Quality Management Systems. Thorough understanding of Clinical R&D activities and Global Regulations. Experience with Regulatory Submission and Inspection Management procedures. Strong analytical, critical thinking, and decision-making abilities. Proven team player with excellent communication skills. What you can expect of us
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement, work/life balance, and career development opportunities. 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. Be careful - Don’t provide your bank or credit card details when applying for jobs. Don't transfer any money or complete suspicious online surveys. Apply now for a career that defies imagination. #J-18808-Ljbffr
What you will do In this vital role, you will report to the Therapeutic Area Quality Lead - Clinical Quality, Clinical & Research Quality (CRQ). As the Senior Manager, Quality & Compliance, you will provide proactive end-to-end quality support for developing and implementing a risk-based quality assurance strategy for the clinical development program. The R&D Process Quality team supports the Quality Management System (QMS) across all Amgen research areas, including discovery through the clinical development lifecycle. This team ensures that all Amgen's business procedures meet internal and external quality standards and are managed for optimum efficiency and effectiveness. Responsibilities Create and maintain data tools to enable stakeholders to ensure quality in the R&D space. Maintain Quality oversight related to continuous improvements (CI) associated with our QMS through metrics and key performance indicators (KPIs). Support the application of process metrics (KQI, KPI - leading and lagging) and modern analytic methods across the Business Process Network to enable Management Reviews. Ensure our CI efforts maintain a quality culture throughout the R&D and GDO organizations. Ensure that all procedures are written clearly for driving Amgen's research tasks within a diverse, complex, cross-functional team of researchers and a rapidly evolving worldwide regulatory framework. Partner with the Business Process Owner network by ensuring risk-based improvements to procedures. Apply risk methodologies to support audits across the R&D network. Apply industry standard methodologies for optimal procedural documentation and the use of technology to drive an efficient knowledge management system. Serve as a GCP Subject Matter Expert, providing independent and objective quality advice. Collaborate with other quality professionals within R&D to support the QMS continuous improvement cycle. Support a robust regulatory intelligence system. What we expect of you
The individual we seek has technological literacy and leadership skills and has these qualifications: Basic Qualifications:
Doctorate degree and 2 years of quality experience OR Masters degree and 6 years of quality experience OR Bachelors degree and 8 years of quality experience OR Associates 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, or programs. Preferred Qualifications:
7 years or more experience in quality management, quality assurance, or other relevant areas of the pharmaceutical/biotech industry. Experience in a coding language like Python or R, is preferred. Skilled translator between technical and non-technical audiences. Demonstrated ability to visualize data for consumption by business stakeholders. Experience in Tableau, is preferred. Direct experience working with standard procedural documentation. Solid understanding of SOP/Standards management. Oversight and implementation of Quality Management Systems. Thorough understanding of Clinical R&D activities and Global Regulations. Experience with Regulatory Submission and Inspection Management procedures. Strong analytical, critical thinking, and decision-making abilities. Proven team player with excellent communication skills. What you can expect of us
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement, work/life balance, and career development opportunities. 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. Be careful - Don’t provide your bank or credit card details when applying for jobs. Don't transfer any money or complete suspicious online surveys. Apply now for a career that defies imagination. #J-18808-Ljbffr