Quality Compliance Manager

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

Overview

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Join Amgen’s Mission of Serving Patients. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer biotech in our fight against serious diseases. Amgen focuses on Oncology, Inflammation, General Medicine, and Rare Disease, reaching millions of patients each year. As part of Amgen, you’ll help make a lasting impact on patients while researching, manufacturing, and delivering innovative medicines. Our culture is collaborative, innovative, and science-based.

If you have a passion for challenges and the opportunities within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What You Will Do

We are hiring a Quality Compliance Manager to operate within the General Medicine & Obesity Quality Therapeutic Area. In this role you will provide proactive end-to-end quality support for the development and implementation of a risk-based quality assurance strategy that advances quality by design principles for the full clinical development program (protocol development, database lock, and regulatory submissions/ approvals). You will report to the Quality Compliance Associate Director and oversee quality management and ensure compliance for global and local clinical trials by supporting study teams and trial sites involved in Amgen-sponsored Trials.

Responsibilities

• GCP Subject Matter Expert — provide independent and objective quality advice in support of clinical trial activities in line with current standard methodology.
• Provide quality oversight for Amgen programs for all stages of products in clinical development.
• Ensure quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to identify, prioritize, and mitigate risks to critical data, processes, patient safety, welfare, and rights.
• Support establishment of regional expertise to ensure quality and compliance with local regulations.
• Support Clinical Trial Teams for quality management activities, including Deviations/CAPAs, Inspection Readiness and Management, and Serious Breaches/Privacy Issues.
• Ensure TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarker usage and imaging methods).
• Review clinical trial protocols to ensure simplification, application of lessons learned, and identification of critical data and processes.
• Actively seek and implement innovative quality oversight methodologies (e.g., risk methods leveraging AI, NLP, and other advanced data analytics).
• Manage or support regulatory inspection and review responses.
• Prepare and analyze data quality indicators/trends, identify gaps, implement corrective actions, and communicate quality metrics to key partners on a periodic basis.
• Support monthly meetings with program-level CPO senior management/associate directors to review ongoing quality issues, trends, timelines, and potential inspections.
• Support response generation for audit findings and self-reported deviations.
• Provide study-specific vendor quality oversight.
• Plan, conduct, and report risk-based Good Clinical Practices (GCP) audits (investigator site audits, affiliate audits, and study-level audits).

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The ideal candidate has technological literacy and leadership skills and the following qualifications:

Basic Qualifications

• Doctorate degree OR
• Master’s degree with 2 years of quality management experience OR
• Bachelor’s degree with 4 years of quality management experience OR
• Associate’s degree with 8 years of quality management experience OR
• High school diploma / GED with 10 years of quality management experience

Preferred Qualifications

• Experience in Quality Management, Quality Assurance, or other relevant pharmaceutical/biotech roles where risk-based quality and quality by design are core responsibilities.
• Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS (e.g., Veeva, TrackWise).
• Thorough understanding of Clinical R&D activities and global regulations.
• Knowledge of regulatory submission and inspection management procedures.
• Quality oversight of clinical trials, including protocol development, execution, and submissions.
• Excellent verbal and written communication skills, including business writing and active listening.
• Ability to translate feedback into clear, efficient processes using straightforward language.
• Strong analytical, critical-thinking, and decision-making abilities.
• Ability to understand and articulate technical concepts in English.

What You Can Expect From Us

We support your professional and personal growth and well-being, with competitive benefits and a collaborative culture. Salary is posted as a range; actual salary varies based on skills, experience, and qualifications. Amgen offers a Total Rewards Plan including health and welfare plans, financial plans for retirement, work/life balance, and career development opportunities.

• Comprehensive benefits package including retirement and savings plan with company contributions, medical, dental, vision insurance, life and disability insurance, and flexible spending accounts.
• Discretionary annual bonus, or sales-based incentive plan for field representatives.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid where possible.

Apply now and make a lasting impact with the Amgen team. Visit careers.amgen.com for more information.

Amgen is an Equal Opportunity employer. We will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by law. We provide reasonable accommodations in the application or interview process upon request.

Application deadline: Amgen does not have a fixed deadline; we will continue accepting applications until we select a candidate.