Senior Manager, In-Vitro Diagnostics/Precision Medicine Quality

For our client, we are seeking a Senior Manager, In-Vitro Diagnostics/Precision Medicine Quality to join the team of a leader in the Pharmaceuticals & Biotech space. This role will provide quality leadership for in-vitro diagnostics and companion diagnostics used in clinical development, with a strong focus on regulatory readiness and global compliance. The position partners closely with diagnostic collaborators, clinical teams, and health authority stakeholders to ensure quality standards are upheld across trial activities. It will also help shape quality strategies, review key agreements and protocols, and strengthen performance through meaningful quality metrics. Location: Remote - US based candidates only, no visa sponsorship available Compensation: $132,037 – $178,638 annually Responsibilities Support quality oversight of in-vitro diagnostic medical devices in clinical trials Provide expertise on regulatory and quality oversight of in-vitro diagnostics and companion diagnostics Manage clinical trial inspections and findings from health authorities Collaborate with diagnostic partners to ensure compliance with quality standards Advance quality management strategies in response to evolving in-vitro diagnostic regulations Assist in the review of quality agreements and clinical trial protocols Contribute to the collection and use of quality metrics for performance improvement Qualifications Doctorate degree with 2 years of relevant experience, or Master's with 4 years, or Bachelor's with 6 years, or Associate's with 10 years, or high school diploma with 12 years of experience in quality, regulatory, or companion diagnostics Experience in the pharmaceutical/biotech, medical device, or biomarker industry, particularly with in-vitro diagnostics and companion diagnostics Familiarity with EU clinical trial sites, either as a site monitor or in study management Knowledge of in-vitro diagnostic medical device development and global regulations related to companion diagnostics and precision medicine Experience with Quality Management Systems (QMS) and compliance to GxP requirements Benefits Comprehensive employee benefits package including medical, dental, and vision coverage Retirement and Savings Plan with generous company contributions Discretionary annual bonus program and stock-based long-term incentives Award-winning time-off plans to support work/life balance Flexible work models where applicable 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.