For our client, we are seeking a Clinical Quality Operations Manager to join the team of a leader in the Pharmaceuticals & Biotech space.
This remote role will oversee quality operations across clinical trial activities, with a focus on strengthening inspection readiness and driving consistent application of quality standards. The position partners closely with trial teams and cross-functional stakeholders to identify risks, resolve study-level quality issues, and support effective regulatory responses. It is well suited for a quality leader who can translate complex clinical and compliance requirements into practical processes that protect study integrity and readiness.
Location: Remote - US based candidates only, no visa sponsorship available
Compensation: $142,400 – $224,100 annually
Responsibilities
Support trial teams in implementing Quality by Design
Serve as a subject matter expert for quality processes and regulatory requirements
Identify and resolve study-level quality issues, including significant quality issues
Lead inspection hypercare teams to maintain inspection readiness
Oversee sponsor inspections and manage inspection response processes
Qualifications
Bachelor’s or Master’s degree in a healthcare or scientific area
Minimum of 8 years of relevant experience in the pharmaceutical industry or clinical research
Strong knowledge of quality management and clinical trial operations
Comprehensive understanding of Quality Management Systems (QMS) and ICH GCP guidelines
Advanced experience in root cause analysis (RCA) and CAPA management
Benefits
Medical, dental, and vision coverage for employees and families
Retirement benefits including 401(k)
Paid holidays and vacation days
Compassionate and sick leave days
Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.