Find & Apply For Clinical Quality Manager Jobs in North Brunswick Township, New Jersey

Company Overview Sonder Research X is developing innovative cancer diagnostics by integrating pathology, advanced imaging, artificial intelligence, and complementary biological data. Our multidisciplinary team works across scientific, engineering, computational, and clinical disciplines to develop novel diagnostic technologies that improve cancer detection and patient care. As Sonder advances toward clinical validation and commercialization, we are committed to building the regulatory and quality capabilities necessary to support sustainable growth while maintaining scientific excellence. Position Overview We are seeking a Regulatory Affairs & Quality Lead to establish and develop Sonder's Regulatory Affairs capability while strengthening the Quality systems needed to support the company's continued growth. This individual will own the development and execution of scalable regulatory strategies and roadmaps, with an immediate focus on advancing Sonder's diagnostic assays through analytical validation and implementation as laboratory-developed tests (LDTs) in a CLIA-certified, CAP-accredited laboratory environment. The role will also serve as the internal owner of Sonder's Quality Management System (QMS), ensuring the processes and controls needed to support consistent, reproducible testing and future commercialization. Working closely with the Clinical Laboratory Director, Research, Clinical Development, Laboratory Operations, Manufacturing, AI, Software Engineering, and Executive Leadership, this individual will translate evolving Regulatory and Quality requirements into practical strategies, processes, documentation, and organizational priorities. The role will provide Regulatory leadership across multidisciplinary initiatives, ensure Quality systems remain effective and scalable, and engage specialized external expertise when appropriate. This hands-on leadership role is ideal for an experienced Regulatory Affairs and Quality professional who understands the clinical laboratory and diagnostic development environment and can assess requirements, identify gaps and priorities, personally drive implementation, and build practical capabilities that support Sonder's progression from assay development and validation through LDT implementation and future diagnostic commercialization. Key Responsibilities Regulatory Affairs Strategy & Leadership Develop, own, and execute Sonder's regulatory strategy and roadmap, with an immediate focus on establishing the requirements and pathway needed to advance the company's first assay through analytical validation and implementation as a laboratory-developed test (LDT) within a CLIA-certified, CAP-accredited laboratory environment. Partner closely with the Clinical Laboratory Director and scientific teams to translate assay development, intended use, and analytical validation activities into clear Regulatory and Quality requirements, documentation, and readiness milestones. Lead Regulatory and Quality planning for LDT implementation and laboratory readiness, identifying applicable

CLIA/CAP

requirements, regulatory risks, evidence needs, gaps, and decision points throughout development. Establish scalable regulatory processes that support the company's near-term LDT objectives while anticipating future evolution toward IVD, companion diagnostic, and device-manufacturing pathways as applicable. Monitor evolving FDA, CMS/CLIA, CAP, and other applicable regulatory requirements and translate regulatory developments into clear, actionable guidance for scientific, clinical, laboratory, product development, and leadership teams. Quality Management Systems Serve as the internal owner of Sonder's Quality Management System (QMS), ensuring the system effectively supports the company's scientific, clinical, regulatory, and operational needs. Implement, maintain, and continuously improve Quality processes, including SOP governance, document control, training, corrective and preventive actions (CAPA), change control, and quality documentation. Coordinate internal audits, support external inspections, and strengthen organizational readiness for increasing Quality and Regulatory requirements. Promote practical, sustainable Quality practices across the organization while ensuring systems remain appropriate for Sonder's stage of growth. Regulatory & Quality Operations Integrate Regulatory and Quality requirements into research, laboratory operations, clinical development, product development, and future commercialization activities. Support laboratory Quality initiatives and future

CLIA/CAP

readiness while ensuring Regulatory and Quality considerations are incorporated early into scientific and operational initiatives. Establish and maintain processes and documentation that provide evidence of Regulatory and Quality compliance and organizational readiness. Cross-Functional Leadership Partner with Research, Clinical Development, Laboratory Operations, Manufacturing, AI, Software Engineering, and Executive Leadership to translate Regulatory and Quality requirements into practical development and business processes. Serve as Sonder's internal Regulatory Affairs and Quality resource, providing clear guidance to multidisciplinary teams and helping drive implementation of required actions. Provide Regulatory and Quality expertise supporting strategic partnerships, clinical initiatives, commercialization planning, and organizational decision-making. Organizational Development Identify gaps in existing Regulatory and Quality capabilities, recommend priorities, and personally drive implementation of practical solutions. Recommend future internal capabilities, external expertise, and resources needed as Sonder's Regulatory and Quality requirements evolve

Requirements:

Bachelor's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, Quality, or a related scientific or technical discipline. 5-8+ years of progressive Regulatory Affairs and/or Quality experience within clinical laboratories, molecular diagnostics, in vitro diagnostics, or another closely related regulated diagnostic environment. Demonstrated experience supporting the development, validation, implementation, or regulatory readiness of laboratory-developed tests (LDTs) or other clinical diagnostic assays. Hands-on experience with Quality Management Systems, including SOP governance, document control, CAPA, change control, training, audit readiness, and processes supporting reproducible laboratory testing. Working knowledge of CLIA and CAP requirements, with experience translating Regulatory and Quality requirements into practical processes across scientific, laboratory, and cross-functional teams. Strong project management, communication, judgment, and cross-functional collaboration skills, with the ability to operate effectively in a hands-on, growth-stage environment. Preferred Qualifications Demonstrated experience helping advance a laboratory-developed test (LDT) from development and analytical validation through implementation in a CLIA-certified and/or CAP-accredited clinical laboratory. Direct experience with

CLIA/CAP

accreditation, inspection readiness, laboratory Quality systems, and implementation of new clinical laboratory testing. Experience establishing or expanding Regulatory and Quality capabilities within a startup, growth-stage, or otherwise developing clinical laboratory environment. Experience with molecular diagnostics, oncology diagnostics, IVDs, ISO 13485, or future FDA-regulated diagnostic/device pathways; relevant professional certifications such as RAC, CQA, or CMQ/OE are a plus. Success in the First 12 Months The successful candidate will establish the regulatory and quality foundation needed to support Sonder's continued growth by: Developing and advancing a scalable regulatory strategy and roadmap aligned with Sonder's clinical validation, diagnostic development, regulatory readiness, and commercialization objectives. Establishing clear regulatory pathways, requirements, priorities, and decision points for future diagnostic products, including LDTs, IVDs, and companion diagnostic opportunities as applicable. Advancing regulatory readiness by coordinating submission and agency planning, identifying regulatory risks and evidence needs, and engaging specialized external expertise when appropriate. Taking internal ownership of Sonder's Quality Management System (QMS) and strengthening practical, sustainable processes for SOP governance, document control, training, CAPA, and change control. Improving organizational readiness for FDA, CLIA, CAP, and future Regulatory and Quality inspections while integrating Regulatory and Quality considerations into scientific, clinical, laboratory, and product development activities. Establishing scalable Regulatory Affairs capabilities and strengthening Quality infrastructure to support Sonder's continued scientific, clinical, and commercial growth.

Visa Sponsorship Requirement:

No, I do not need sponsorship now or in the future

Sonder's Recruiting & Hiring Process:

Sonder Research X Recruiting & Hiring Process We appreciate your interest in joining Sonder Research X. Applications are reviewed on a rolling basis, and we typically identify qualified candidates for the next stage within 3-5 business days.

Application Review:

We will review applications to identify candidates whose experience and qualifications most closely align with the position's requirements.

Brief One-Way Video Interview:

Selected candidates will be invited to complete a short one-way video interview with three questions about their prior Regulatory Affairs and Quality experience. Candidates will have a brief period to prepare before recording each response. No advance preparation is required.

First Interview:

Candidates who advance from the video interview will meet with our Senior Manufacturing Engineer to discuss their background, relevant experience, and alignment with the role's needs.

Second Interview:

Selected candidates will meet with one of our scientists supporting Sonder's regulatory efforts for a deeper discussion of quality systems, regulatory experience, and how they have approached challenges in previous roles.

Case Study:

Finalists will complete a brief, practical case study designed to understand how they approach real-world quality and regulatory challenges. Candidates may draw upon prior experience without sharing confidential or proprietary information.

Final Interview:

Candidates who successfully complete the case study will meet with our CEO/CSO for a final conversation about the role, Sonder's direction, and mutual fit. Our goal is to conduct a thoughtful and efficient process while giving both Sonder and each candidate the opportunity to determine whether there is a strong fit. The full hiring process may take approximately 3-4 weeks, depending on scheduling and candidate availability. We appreciate your patience and will keep candidates informed as they progress through each stage. Thank you for your interest in Sonder Research X. We look forward to learning more about your experience and the perspective you could bring to our team.

Benefits:

The comprehensive benefits package includes medical, dental, and vision coverage, generous paid time off, a 401(k), an annual professional development budget, and a Coursera subscription. Location & Relocation Assistance This onsite position is based in North Brunswick, New Jersey. Candidates located outside of New Jersey are encouraged to apply. Relocation assistance will be considered for highly qualified candidates. Why Join Sonder Research X? At Sonder Research X, you'll have the opportunity to help build a critical capability at an important stage in our company's growth. Your work will directly influence how we strengthen our quality systems, prepare for increasing regulatory requirements, and advance our novel cancer research toward clinical validation and future commercialization. This role offers significant opportunity for professional growth as Sonder's quality and regulatory needs continue to evolve. You'll have the opportunity to take meaningful ownership, expand your scope and responsibility, and grow alongside a company advancing innovative approaches to cancer detection and diagnosis.