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Clinical Quality Oversight Manager
hace 1 semana
Quality Leadership at Amgen SA
At Amgen, our mission to serve patients drives all we do. As a leading biotechnology company, we collaborate globally to research, manufacture, and deliver innovative products that reach millions worldwide.
As Clinical Quality Oversight Manager, you will play a vital role in advancing quality by design principles for the full clinical trial lifecycle. Reporting to the Therapeutic Area Quality Lead - Clinical & Research Quality (CRQ), you will provide proactive end-to-end quality support for the development and implementation of risk-based quality assurance strategies.
Responsibilities:
- Serve as a GCP Subject Matter Expert, providing independent and objective quality advice in support of clinical trial activities and in line with current standard processes.
- Provide quality oversight for Amgen programs at all stages of product development.
- Plan, conduct, and report on risk-based GCP audits or support outsourced audits.
- Manage regulatory inspections and provide guidance and feedback on responses to health authorities, including root cause and CAPA plans.
- Support monthly meetings with clinical program-level leaders to review quality and compliance-related risks.
- Conduct new vendor qualifications/evaluations in a risk-based manner.
- Prepare, analyze, and identify data quality indicators/trends, recommend corrective actions, and communicate quality metrics to key collaborators.
- Actively seek and implement innovative quality oversight methodologies.
Requirements:
- 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 2 years of experience managing people and/or leadership experience leading teams, projects, programs, or directing resource allocation.
- 7 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry.
Salary: Estimated $120,000 - $180,000 per annum, depending on experience.
What We Offer:
- Comprehensive employee benefits package, including a retirement plan, medical, dental, and vision coverage, life insurance, disability insurance, and flexible spending accounts.
- Discretionary annual bonus program.
- 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.