Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

Amgen's shared mission to serve patients drives all that we do. We are global collaborators researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. This role provides 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.

Responsibilities

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, including protocol development, database lock, and regulatory submissions/approvals.
Oversee quality management and ensure compliance for global and local clinical trials by supporting study teams and trial sites involved in Amgen-sponsored Trials.
Serve as the GCP quality SME, providing independent quality guidance for clinical trial activities aligned with global regulations and best practices.
Oversee quality and compliance across all stages of clinical development programs, including risk management through RACT and protection of patient safety, rights, and data integrity.
Support clinical trial teams with quality management activities such as deviations/CAPAs, inspection readiness, serious breaches, privacy issues, and regulatory inspection responses.
Review protocols and trial processes to drive simplification, apply lessons learned, and identify critical data and operational risks.
Implement innovative, risk-based quality oversight approaches using advanced analytics, AI, and NLP methodologies.
Monitor and analyze quality metrics and trends, identify gaps, and recommend corrective and preventive actions to stakeholders and senior leadership.
Provide vendor quality oversight and support regional compliance with local regulations and regulatory requirements.
Plan, conduct, and report risk-based GCP audits, including investigator site, affiliate, and study-level audits.

Requirements

Strong experience in GCP within Clinical R&D, Quality, or Study Management environments.
Knowledge of electronic Quality Management Systems (e.g., Veeva, TrackWise) and clinical trial oversight processes.
Solid understanding of clinical development, protocol execution, regulatory submissions, and inspection management.
Proven ability to support operational and quality oversight of clinical trials from development through submission.
Excellent written and verbal communication skills, including business writing and stakeholder engagement.
Strong analytical, critical-thinking, and problem-solving capabilities with the ability to simplify complex processes and technical concepts.
Background in Quality Management/Assurance and risk-based quality approaches within the pharmaceutical or biotech industry is preferred.

Skills

GCP
Clinical R&D
Quality
Study Management
Electronic Quality Management Systems
Veeva
TrackWise
Clinical trial oversight
Clinical development
Protocol execution
Regulatory submissions
Inspection management
Risk-based quality approaches
Advanced analytics
AI
NLP
Communication skills
Business writing
Stakeholder engagement
Analytical skills
Critical-thinking
Problem-solving

Location

Cambridge
Uxbridge

Work Type

Flexible from home
Regular office work

Experience Level

Experienced professional

Education Level

Degree educated

Benefits

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

About the Company

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.
A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Equal Opportunity

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request an accommodation.