GCP Quality Compliance Manager

Amgen; Hartford; On-site; GBP 40,000 - 55,000; Full time

Job summary

A leading biotechnology company in Hartford is seeking a Quality Management Specialist to provide critical support in maintaining and improving the Quality Management System (QMS). The ideal candidate will have a degree, experience in Quality Management, and a thorough understanding of Clinical R&D and GCP. This role offers vast opportunities for professional development and a diverse, inclusive community.

Benefits

Opportunities for career advancement

Inclusive work environment

Generous Total Rewards Plan

Qualifications

• Degree educated, preferably in a science-related field.
• Experience in Quality Management, Quality Assurance, or related areas in pharmaceuticals.
• Strong understanding of Clinical R&D activities and Global Regulations.

Responsibilities

• Maintain and improve the Quality Management System (QMS).
• Collect, analyze, and report quality metrics (KPIs/KQIs).
• Ensure compliance with GCP standards and regulatory requirements.

Skills

Quality Management

Analytical skills

Collaboration

Decision-making

Communication skills

Education

Degree in relevant field

Job description

Overview

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.

Responsibilities

• 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.

Qualifications

• 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.

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