GCP Quality Compliance Manager

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION

If you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

GCP QUALITY COMPLIANCE MANAGER

LIVE

What you will do

In this vital 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 including protocol development database lock and regulatory submissions/ approvals. You will operate within

Reporting to the Quality Compliance Associate Director you will 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.

Be part of our team

You would be joining the R&D Quality team operating within Obesity Therapeutic Area.

WIN

What we expect of you

We are all different yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional are these qualifications and skills:

• 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.
• Degree educated.

THRIVE

What you can expect of us

As we work to develop treatments that take care of others so we work to care for our teammates professional and personal growth and well-being.

• 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

LOCATION: Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.

APPLY NOW

for a career that defies imagination

In our quest to serve patients above all else Amgen is the first to imagine and the last to doubt. Join us.

Equal Opportunity Statement

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.