Senior Manager, Clinical Quality Therapeutic Area - Remote

Overview

This position is for a Senior Manager in Clinical Quality at Amgen, focusing on quality oversight in therapeutic areas including Oncology, Inflammation, General Medicine, and Rare Disease.

In Short

• Provide end-to-end quality oversight for clinical trials.
• Develop risk-based quality management activities.
• Review clinical trial protocols for quality and compliance.
• Support management of quality and compliance for clinical trial sites.
• Implement innovative quality oversight methodologies.
• Manage quality assurance plans and audits.
• Ensure adherence to local regulations and standards.
• Lead teams and manage resources effectively.
• Utilize advanced data analytics for quality management.
• Collaborate with cross-functional teams to ensure quality standards.

Requirements

• Doctorate degree with 2 years of quality experience or equivalent.
• Minimum 2 years of managerial experience.
• 5+ years in Quality Management or related fields.
• Experience with Quality Management Systems.
• Understanding of Clinical R&D and Global Regulations.
• Strong communication and analytical skills.
• Ability to lead and manage projects effectively.
• Proficiency in English, both spoken and written.
• Familiarity with AI and data analytics in quality management.
• People leadership and managerial expertise.

Benefits

• Comprehensive employee benefits package.
• Retirement and Savings Plan with company contributions.
• Group medical, dental, and vision coverage.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote arrangements.
• Career development opportunities.
• Support for professional and personal growth.
• Inclusive and collaborative culture.