Remote Compliance & QA Analyst (Technology)

WCG Clinical, Inc.; Montpelier (VT); Remote; USD 52,000 - 82,000; Full time

Job summary

WCG is seeking an Associate, Compliance & QA (Technology) to support and maintain the Quality Management System across Technology Solutions, ensuring alignment with FDA/ICH, GCP, GDPR, and HIPAA standards. You will partner with IT, engineering, and operations to embed compliance in processes and systems.

The role emphasizes quality documentation, training, and cross-department collaboration, with responsibilities spanning internal audits, CAPA, validation, and regulatory alignment.

Qualifications

• Two to four years of experience in a quality/regulatory compliance role
• Knowledge of FDA & ICH guidelines and GCP as they apply to clinical studies
• Experience supporting customer/sponsor audits of processes, training, and documentation
• Knowledge of 21 CFR Part 11 and Computerized System Validation
• Experience documenting and executing computerized system validation efforts for Clinical Trials
• Strong written and verbal communication skills and ability to work across departments

Responsibilities

• Maintain and enhance the Quality Management System and quality department standards
• Support achievement of quality goals, objectives, and process improvements
• Educate staff on quality standards and best practices
• Develop and revise internal technology standards and SOPs
• Support validation, implementation, and change management in line with regulatory requirements
• Assist in CAPA investigations, deviations, and notes to file
• Conduct internal and external audits and support audit preparations
• Stay current with quality legislation and regulatory best practices
• Participate in multi-departmental projects and cross-functional workstreams

Skills

Regulatory compliance

Quality assurance

Technical writing

Audit support

GxP knowledge

Communication

Problem-solving

Education

Bachelor's degree in a scientific/technical field

Job description

WCG is seeking an Associate, Compliance & QA (Technology) to support and maintain the Quality Management System across Technology Solutions, ensuring alignment with FDA/ICH, GCP, GDPR, and HIPAA standards. You will partner with IT, engineering, and operations to embed compliance in processes and systems.

The role emphasizes quality documentation, training, and cross-department collaboration, with responsibilities spanning internal audits, CAPA, validation, and regulatory alignment.