GCP Quality Compliance Manager
What you will do
* 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.
* Serve as the GCP quality SME, providing independent quality guidance 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 the Obesity Therapeutic Area.
What we expect of you
* 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 in a relevant field.
What you can expect of us
* 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.
Equal Opportunity StatementAmgen 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.
#J-18808-Ljbffr