Senior Quality and Compliance Specialist – Homebased, UK (GCP & CRO Experience)

Role Overview

The Senior Quality and Compliance Specialist will maintain a strong understanding of regulations and guidance as they pertain to compliance, and will be responsible for planning, preparing, and conducting GCP audits independently.

What You Will Do

The role involves developing CAPA plans, contributing to the resolution of audit findings, and monitoring vendors and clinical investigator sites to ensure processes are followed and quality is maintained.

Why It Might Be a Fit

The ideal candidate will have a strong understanding of scientific principles and concepts, and will be proficient in MS Office applications. They will also have good communication and problem-solving skills, and will be willing to travel up to 30% of the time for audits within the UK/EU.

Requirements

• College graduate in scientific, medical, clinical discipline or related experience, Masters preferred; or minimum of 7 years’ experience in GCP regulated industry if not a college graduate
• Minimum of 5 years’ experience in GCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor.)
• Expert knowledge of scientific principles and concepts
• Proficiency with MS Office applications
• Hands-on experience with clinical trial and pharmaceutical development preferred
• Good communication skills and willingness to work with others to clearly understand needs and solve problems
• Excellent problem-solving skills
• Good organizational and communication skills
• Proficient with 21 CFR Part 11, FDA, and GxP requirements
• Expertise within CROs and scientific and clinical data/ terminology, and the drug development process

Benefits

• Dental insurance
• Vision insurance
• Health insurance
• Paid holidays
• Relocation assistance