Job Description

About BOSTONGENE

BostonGene is redefining precision medicine with its AI-powered, multiomic approach to understanding and treating complex diseases. By integrating deep molecular profiling—including genomics, proteomics and the immune system—the platform delivers a systems biology view that accelerates drug development and clinical decision-making. With a CLIA-certified, CAP-accredited lab, BostonGene provides clinically validated insights that personalize care and support translational breakthroughs. Partnering with leading pharma, biotech and cancer centers, BostonGene drives innovation and advances transformative therapies.

Position Overview

BostonGene is seeking a Head of Quality Assurance and Regulatory Affairs to spearhead and enhance our regulatory strategy and quality management programs across all laboratory operations. This includes our CAP/CLIA-certified and GCLP-compliant high complexity molecular laboratory, with a specific emphasis on implementing compliant AI and machine learning (ML) approaches in our ongoing commercial partnerships and collaborations. As an organization, we maintain and develop a vast suite of software tools and databases that need to be compliant and audit-ready. As a member of the leadership team, this role will be responsible for establishing and leading a robust QMS team, driving enterprise-wide compliance, fostering a strong quality culture, and navigating complex regulatory engagements, particularly with our pharmaceutical and biotech partners. This role requires a strategic leader with a deep regulatory background and proven experience in client-facing roles, especially with large pharma sponsors and familiarity with innovative diagnostic technologies.

Key Responsibilities:

Quality Leadership and QMS Implementation:

• Champion a proactive quality culture and lead the strategic design, development, and implementation of a robust Quality Management System (QMS) across all laboratory operations.
• Ensure the QMS meets and exceeds CAP/CLIA and GCLP standards, focusing on documentation, processes, and controls that support regulatory compliance and operational excellence.
• Oversee the maintenance and continuous improvement of the QMS, including internal audits, corrective and preventive actions (CAPA), and change control management within both GCLP and CLIA frameworks.
• Establish and manage a document control system that ensures all quality and regulatory documents are current, accurate, and accessible in compliance with GCLP and CLIA requirements.

Regulatory Compliance and Strategy:

• Develop and lead the regulatory strategy for all BostonGene laboratory products and services, ensuring proactive compliance with CAP, CLIA, GCLP, and evolving industry and medical device regulations including FDA and PMDA standards.
• Lead regulatory readiness efforts, including high-stakes inspections and direct engagement with external agencies and client QA teams, with a focus on QMS documentation and implementation.
• Oversee global regulatory risk assessment and mitigation strategies across clinical and research labs, ensuring alignment with QMS protocols and procedures.

Client Oversight:

• Act as a strategic advisor and escalation point for all quality and regulatory interactions with pharmaceutical clients, particularly concerning QMS policies and procedures.
• Ensure client audits and regulatory reviews, especially those focused on quality management practices, are handled with precision and professionalism.
• Support the expansion of client partnerships by aligning QMS practices with client expectations and global compliance standards.

Team & Organizational Leadership:

• Build and lead high-performing Regulatory and Quality teams with a focus on QMS management, GCLP/CLIA compliance, and cross-functional integration across laboratory, product development, and software teams.
• Collaborate closely with senior leaders in Lab Operations, R&D, Clinical Affairs, and Legal to ensure a cohesive quality and compliance strategy centered on a robust QMS.
• Provide regulatory and QMS expertise on new service development, assay validation, and expansion into new markets or regulatory jurisdictions.

Preferred Skills:

• Quality Management Systems (QMS): Expertise in designing, implementing, and maintaining robust QMS compliant with CAP/CLIA and GCLP standards. Strong understanding of documentation, processes, controls, internal audits, CAPA, and change management.
• Regulatory Strategy and Compliance: Proven ability to develop and lead regulatory strategies, ensuring compliance with CAP, CLIA, GCLP, and evolving industry regulations. Experience with regulatory readiness, inspections, and engagement with external agencies.
• Data Security Regulations: Deep understanding and experience with data security and privacy regulations, including GDPR, HIPAA, and relevant international standards, ensuring data privacy and security in laboratory operations and data management.
• FDA and PMDA Device Regulations: Comprehensive knowledge and experience with FDA and PMDA device regulations, including pre-market submissions, post-market surveillance, and quality system requirements for medical devices.
• Client Relationship Management: Strong ability to act as a strategic advisor and escalation point for quality and regulatory interactions with pharmaceutical clients. Experience in managing client audits and ensuring alignment of QMS practices with client expectations.
• Team Leadership and Collaboration: Proven ability to build and lead high-performing Regulatory and Quality teams. Excellent collaboration skills to work effectively with Lab Operations, R&D, Clinical Affairs, and Legal teams to implement regulatory policy across the organization.
• Risk Management and Mitigation: Experience in conducting global regulatory risk assessments and developing mitigation strategies, ensuring alignment with QMS protocols and procedures.
• Document Control and Management: Expertise in establishing and managing document control systems that ensure all quality and regulatory documents are current, accurate, and accessible.

Qualifications:

• Advanced degree (MS, MPH, PhD, PharmD, or JD) strongly preferred.
• 10+ years of progressive leadership in regulatory affairs and quality within a clinical stage biotechnology company, clinical diagnostic laboratory, or multiomic CRO, with experience in AI/ML-based systems.
• Background in oncology, molecular diagnostics, or bioinformatics-based services with specific knowledge of AI/ML applications.
• Deep expertise in CAP/CLIA and GCLP regulated environment; practical understanding with ICH, FDA, PMDA and EMA guidelines.
• ISO 13485 for medical device quality management systems, relevant EU IVDR (In Vitro Diagnostic Regulation), and other global regulatory requirements for software as a medical device (SaMD) and in vitro diagnostics (IVD) a plus.
• Strong track record managing audits from global pharmaceutical companies and acting as a regulatory liaison for complex collaborations, including those involving AI/ML technologies.
• Demonstrated success in building and maintaining quality management systems and scalable regulatory infrastructures, with specific experience in validating AI/ML algorithms in a diagnostic setting.

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