Senior Manager, In-Vitro Diagnostics/Precision Medicine Quality

Location: United States - Remote

Salary: $132,037.30-$178,638.70 annually

Company

hirify.global is a biotechnology company developing and delivering medicines for serious illnesses across multiple therapeutic areas.

What you will do

• Support quality oversight of in-vitro diagnostic medical devices, companion diagnostics, laboratory-developed tests, and assays used in precision and digital medicine clinical trials.
• Develop and implement proactive, risk-based quality strategies in collaboration with diagnostic partners and testing laboratories.
• Support health authority inspections, including inspection readiness, findings management, drug and device inspections, audits, and deviation management.
• Provide subject matter expertise on IVD regulations, EU clinical performance studies, US IDE requirements, and companion diagnostic quality strategies.
• Review quality agreements, clinical trial protocols, informed consent forms, and IRB applications.
• Track quality metrics and regulatory developments to improve the quality management system and communicate business impact.

Requirements

• Doctorate degree plus 2 years, master’s degree plus 4 years, bachelor’s degree plus 6 years, associate’s degree plus 10 years, or high school diploma/GED plus 12 years of quality, regulatory, or companion diagnostic experience.
• Experience in pharmaceutical, biotechnology, medical device, biomarker, or related clinical research environments involving IVDs and preferably companion diagnostics.
• Knowledge of IVD medical device development, design controls, EU IVDR, the FDA Companion Diagnostic Final Rule, and global precision medicine regulations.
• Experience with quality management systems, including electronic QMS platforms such as Veeva or TrackWise.
• Experience with GxP compliance and oversight of third-party vendors, suppliers, and partners.
• Strong analytical, critical-thinking, decision-making, collaboration, and process improvement skills.

Nice to have

• Experience at EU clinical trial sites as a site monitor or study manager.
• Experience with companion diagnostic or assay development, CLIA-certified laboratories, or ISO 15189-certified laboratories.
• Experience with EU IVD performance studies and quality oversight activities such as CAPA, audits, or inspection support.
• Experience applying quality-by-design principles and analytics for signal detection and quality improvement.

Culture & Benefits

• Collaborative, innovative, and science-based working environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus and stock-based long-term incentives.
• Paid time-off programs, work-life balance support, and career development opportunities.

Hiring process

• Applications are accepted until a sufficient number of candidates are received or a candidate is selected.
• Visa sponsorship is not guaranteed.