Senior Manager, Diagnostic (IVD) and Laboratory Operational Quality Lead - Remote

Overview

We are seeking a Senior Manager, Diagnostic (IVD) and Laboratory Operational Quality Lead to join our Precision Medicine Team! In this role, a typical day might include driving cross-functional excellence across diagnostic operations, quality & compliance execution, and clinical diagnostic delivery.

In Short

• Drive cross-functional collaboration to design IVD assessment processes and tools.
• Own and manage the IVD assessment process and tools.
• Oversee activities of external partners and vendors to ensure high quality.
• Serve as a subject matter expert during diagnostic & clinical vendor lab audits.
• Collaborate with internal key stakeholders and laboratory vendors.
• Support quality activities for new product development.
• Communicate effectively with stakeholders and escalate risks.
• Participate in audit planning, execution, and follow-up activities.
• Engage with relevant internal and external collaborators.
• Ensure adherence to global IVD regulations and quality requirements.

Requirements

• Minimum Bachelor's Degree (Master’s level preferred) with 8 years of relevant experience.
• Expertise in IVD applications in the clinical trial setting.
• Solid understanding of global regulatory requirements.
• Strong understanding of laboratory practices and validation procedures.
• Proficient in business technology tools (e.g., Microsoft Teams, Excel).
• Drug development experience preferred.
• Strong communication and presentation skills.
• Highly organized with a strategic mindset.
• Experience working with cross-functional clinical study teams.
• Must be able to travel up to 25%.

Benefits

• Comprehensive health and wellness programs.
• Fitness centers and equity awards.
• Annual bonuses and paid time off.
• Inclusive and diverse culture.
• Opportunities for professional growth.