Quality Compliance Leader — Remote Clinical QA & AI-Driven

Amgen; United States; Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Comprehensive benefits package

Discretionary annual bonus

Flexible work models

Stock-based long-term incentives

Award-winning time-off plans

Job summary

A leading biotechnology company in the United States is seeking a Quality Compliance Manager to oversee quality management for clinical development. The ideal candidate will have extensive experience in quality assurance and a strong understanding of regulatory requirements. This role offers a collaborative environment focused on patient impact and allows for hybrid work models. Join us in transforming patients' lives while advancing your career.

Qualifications

• Doctorate degree or equivalent experience in quality management.
• Minimum of 2 years quality management experience for Master's degree.
• Strong understanding of Clinical R&D activities and global regulations.

Responsibilities

• Provide independent quality advice for clinical trials.
• Ensure quality oversight for clinical development programs.
• Manage regulatory inspection responses and data quality indicators.

Skills

Quality Management

Analytical skills

Leadership skills

Communication

Critical thinking

Education

Doctorate degree

Master’s degree with 2 years of experience

Bachelor’s degree with 4 years of experience

High school diploma / GED with 10 years of experience

Tools

Veeva

TrackWise

Job description

A leading biotechnology company in the United States is seeking a Quality Compliance Manager to oversee quality management for clinical development. The ideal candidate will have extensive experience in quality assurance and a strong understanding of regulatory requirements. This role offers a collaborative environment focused on patient impact and allows for hybrid work models. Join us in transforming patients' lives while advancing your career.