Amgen Inc. is hiring a Senior Manager, Clinical Quality Therapeutic Area to provide proactive, end-to-end quality oversight through risk-based quality management activities. In this role, you will develop deep knowledge of clinical trials and provide oversight and quality management of critical data and processes for global and local study teams and clinical trial sites.
What You'll Do
- Review clinical trial protocols to ensure 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 proper risk identification, prioritization, and mitigation.
- 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.
- Develop TA-specific Quality Assurance plans that are risk based and efficient, including audit plans and execution.
- Support Clinical Trial Teams for all quality management activities, including Deviations/CAPAs, Inspection Readiness, Inspection Management, and Serious Breaches/Privacy Issues.
- Actively seek and implement innovative and proactive quality oversight methodologies, such as risk-methods leveraging AI and Natural Language Processing, and other advanced data analytics.
What We're Looking For
- 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.
- Minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.
Nice to Have
- 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 Trackwise.
- 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.
- Strong analytical, critical-thinking, and decision-making abilities.
- Capability to understand and articulate technical concepts and literature in spoken and written English.
Team & Environment
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, reporting to one of the TA Quality Leads within Clinical & Research Quality (CRQ).
Benefits & Compensation
- Compensation range: $147,004 - $174,757 USD.
- 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.
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models, including remote and hybrid work arrangements, where possible.
Work Mode
This role is hybrid, with work locations in the U.S. (excluding Puerto Rico).
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.
