Clinical Quality Assurance Contractor

Bayside Solutions - Redwood City, CA

Full-time - Mid Level

Remote - Redwood City, CA

Sporting Goods, Hobby, Musical Instrument, Book, and Miscellaneous Retailers

About the position

The Clinical Quality Assurance Contractor will provide essential compliance support for sponsored clinical trials, ensuring adherence to Standard Operating Procedures and regulatory requirements. This role involves collaboration with clinical functions to promote Good Clinical Practice (GCP) compliance and risk-based quality management, while also participating in audit preparations and inspections.

Responsibilities

• Collaborate with clinical functions to support GCP compliance.
• Participate in clinical study execution teams to enable risk-based quality management.
• Perform quality review of clinical trial documents focusing on compliance and regulatory requirements.
• Collaborate with internal stakeholders and auditors to support GCP audits.
• Provide risk-based quality oversight for clinical trial activities.
• Support Inspection Readiness activities.
• Assess and coordinate activities related to quality issues in GCP and clinical trial conduct.
• Escalate identified issues to QA Management as needed.
• Enable other assigned GCP or GXP-related tasks as appropriate.

Requirements

• Bachelor's degree in a scientific or technical discipline.
• 12+ years of experience in GCP Quality in the pharmaceutical or biotechnology industry.
• Extensive knowledge of ICH GCP and regulatory requirements (FDA, EMA).
• Effective verbal and written communication skills.
• Ability to build and sustain positive relationships with stakeholders.
• Ability to critically evaluate and troubleshoot complex problems.
• Highly proficient with Microsoft Office and other computerized systems.

Nice-to-haves

• Knowledge of Computer System Validation is preferred.

Benefits

• Remote work flexibility
• W2 contract position