Senior GCP Quality & Compliance Leader

MMS Holdings Inc; Greater London; Hybrid; GBP 55,000 - 85,000; Full time

Job summary

MMS Holdings Inc is seeking a GCP Auditor to join our team. The role focuses on regulatory compliance, quality systems, and independent CAPA development in a CRO environment.

Travel up to 30% within the UK/EU is expected. Strong knowledge of 21 CFR Part 11, FDA, and GxP is required, along with excellent communication and problem-solving abilities to support audits and regulatory submissions.

Qualifications

• 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 (Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor).
• Expert knowledge of scientific principles and concepts.
• Proficiency with MS Office applications.

Responsibilities

• Maintain compliance with regulations and guidance related to audits.
• Plan, prepare and conduct GCP audits independently.
• Author and manage audit documents independently.
• Develop CAPA plans and contribute to resolution of audit findings independently.
• Monitor vendors and clinical investigator sites to ensure processes are followed and quality is maintained.
• Assist in other duties related to compliance within Quality and Compliance.
• Willingness to travel up to 30% for audits in the UK/EU.

Skills

Strong communication

Problem-solving

Organizational skills

Regulatory knowledge

Willingness to travel

Team collaboration

Attention to detail

Education

Bachelor's degree in scientific/medical/clinical discipline

Masters preferred

Tools

MS Office

Job description

MMS Holdings Inc is seeking a GCP Auditor to join our team. The role focuses on regulatory compliance, quality systems, and independent CAPA development in a CRO environment.

Travel up to 30% within the UK/EU is expected. Strong knowledge of 21 CFR Part 11, FDA, and GxP is required, along with excellent communication and problem-solving abilities to support audits and regulatory submissions.