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Sr Manager, Process Quality

3 months ago

Washington, Washington, D.C., United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.Senior Manager, Quality & Compliance

LIVEWhat you will do

Lets do this. Lets change the world. 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 play a crucial part in our mission, providing 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 Amgens business procedures meet internal and external quality standards and are managed for optimum efficiency and effectiveness. The Process Quality team also ensures that Amgens 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, including QMS analytics showing quality signals and trends.Responsibilities

Supports Amgens procedural framework so that all procedures maintain compliance with 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. Serve as a GCP Subject Matter Expert, providing independent and objective quality advice supporting business procedures managed by Business Process Owners (BPOs). Maintain Quality oversight related to continuous improvements (CI) associated with our QMS through metrics and key performance indicators (KPIs) Supports the application of process metrics (KQI, KPI - leading and lagging) and modern analytic methods across the Business Process Network to enable Management Reviews (periodic review by management to ensure QMS health is maintained). Ensures our CI efforts maintain a quality culture throughout the R & D and GDO organizations. Ensures that all procedures are written clearly for driving Amgens 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 to ensure that they are simple, efficient, and fit for purpose while maintaining regulatory compliance. Applies risk methodologies to selectively audit business processes across the R&D network that will ensure improvements to procedures through robust root cause analysis and CAPA aimed at improving procedures. Applies industry standard methodologies for optimal (standardized and lean) procedural documentation and the use of technology to drive an efficient and effective knowledge management system. 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). Supports a robust regulatory intelligence system by monitoring changing regulations and ensuring that the BPO network incorporates changes efficiently and timely. WinWhat we expect of you We are 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 and 2 years of quality experience OR Masters degree and 6 years of quality experience OR Bachelors degree and 8 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, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above Preferred Qualifications: 7 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility.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. Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMSs such as Veeva or Trackwise. 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. Strong Process Mind and analytically oriented - experience with process monitoring, including applying analytical methods and modern technology to enable signal detection and quality improvement.Proven team player takes direction and can rapidly learn and support a hard-working team, making rapid decisions and communicating them promptly.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.ThriveWhat you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. 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. Amgen offers a Total Rewards Plan comprising 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 including: 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 and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Apply nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. 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. 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. 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.