Senior Quality and Compliance Specialist - Remote

Overview

The Senior Quality and Compliance Specialist at MMS is responsible for ensuring compliance with regulations and conducting GCP audits, contributing to the overall quality assurance within the organization.

In Short

• Maintain understanding of compliance regulations and updates.
• Plan and conduct GCP audits independently.
• Author and manage audit documents.
• Develop CAPA plans for audit findings.
• Monitor vendors and clinical sites for quality assurance.
• Assist with compliance-related duties as needed.
• Willingness to travel up to 30% for audits in the US.

Requirements

• College graduate in a scientific or medical discipline, or 7 years of experience in a GCP regulated industry.
• Minimum of 5 years in a GCP regulated industry.
• Expert knowledge of scientific principles.
• Proficiency in MS Office applications.
• Experience with clinical trials and pharmaceutical development preferred.
• Good communication and problem-solving skills.
• Excellent organizational skills.
• Proficient with 21 CFR Part 11 and FDA regulations.
• Expertise in CROs and drug development processes.

Benefits

• Competitive salary and benefits package.
• Opportunity to work in a global and diverse environment.
• Continuous training and development opportunities.
• Collaborative and enthusiastic work culture.