GCP Quality Compliance Manager in Cambridge

## **Career Category**Quality## ## **Job Description**If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s 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 critical support to the Process Quality function by assisting in the implementation, monitoring, and continuous improvement of Amgen’s R&D Quality Management System (QMS) and Regional Quality Oversight.* Maintain and improve the QMS by tracking, documenting, and implementing quality initiatives to meet regulatory requirements.* Collect, analyze, and report quality metrics (KPIs/KQIs) to identify trends, risks, and opportunities for improvement.* Ensure compliance with GCP standards and regulatory requirements across R&D.* Act as liaison between Process Quality and Global Networks to enable smooth collaboration.* Provide quality oversight at key sites, including readiness checks (remote/onsite) and risk assessments for audits.* Identify data quality gaps, recommend and implement corrective actions.* Coordinate and support inspections and audits (preparation, conduct, closeout, and responses).* Apply project management, root cause analysis, and corrective/preventive action follow-up.* Integrate data, trends, and insights into plans and recommendations.* Act as a subject matter expert in GCP and SOP/Standards management.**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:* Degree educated* Previous experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility* Thorough understanding of Clinical R&D activities, Global Regulations and GCP* Strong analytical, critical thinking, collaborative and decision-making abilities* Excellent written and verbal communication skills**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. Onsite domestic travels required.**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.**careers.amgen.com****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.. #J-18808-Ljbffr