Senior Quality and Compliance Specialist (GCP)

TL;DR

Senior Quality and Compliance Specialist (GCP): Maintaining regulatory compliance, conducting GxP audits, and supporting quality management processes for pharmaceutical, biotech, and medical device clients with an accent on vendor monitoring and clinical site oversight. Focus on planning independent audits, managing compliance projects, and ensuring adherence to GCP standards in drug development.

Remote, must be willing to travel up to 30% of the time for audits within the US and internationally as needed

Company

hirify.global is an innovative, data-focused CRO supporting pharmaceutical, biotech, and medical device industries with scientific solutions for trial data and regulatory challenges.

What you will do

• Maintain strong understanding of regulations, guidance, and updates related to compliance.
• Plan, prepare, and conduct GxP audits independently.
• Support clients in developing or refining Quality Management Processes or Systems.
• Manage projects related to quality and compliance activities.
• Author and manage audit documents independently.
• Monitor vendors and clinical investigator sites to ensure process adherence and quality maintenance.

Requirements

• College graduate in scientific, medical, or clinical discipline (Masters preferred) or minimum 7 years in GCP regulated industry
• Minimum 5-7 years experience in GCP regulated industry (e.g., Clinical Research Coordinator, CRA, or GCP Auditor)
• Expertise in CROs, scientific/clinical data/terminology, and drug development process
• Experience with project oversight: document management, vendor qualifications, training management
• Proficiency with MS Office applications
• Hands-on experience with clinical trials and pharmaceutical development preferred
• Strong communication, problem-solving, organizational skills, and technical writing
• Proficiency with applicable regulatory requirements

Culture & Benefits

• Global footprint across four continents with 97% customer satisfaction.
• Fosters enthusiasm, collaboration, and teamwork in a diverse talent pool.
• Focus on identifying top talent, continual training, and strengthening core skills.