BostonGene
Head of Quality Assurance & Regulatory Affairs
BostonGene, Waltham, Massachusetts, United States, 02254
Head of Quality Assurance & Regulatory Affairs
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.
QMS Compliance:
Ensure the QMS meets and exceeds CAP/CLIA and GCLP standards, focusing on documentation, processes, and controls that support regulatory compliance and operational excellence.
QMS Maintenance and Improvement:
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.
Document Control:
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.
Regulatory Readiness:
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.
Global Regulatory Risk:
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.
Audits and Reviews:
Ensure client audits and regulatory reviews, especially those focused on quality management practices, are handled with precision and professionalism.
Partnership Expansion:
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.
Cross-Functional Collaboration:
Collaborate 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.
New Services and Markets:
Provide regulatory and QMS expertise on new service development, assay validation, and expansion into new markets or regulatory jurisdictions.
Preferred Skills
QMS Expertise:
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:
Ability to develop and lead regulatory strategies, ensuring compliance with CAP, CLIA, GCLP, and evolving industry regulations; experience with regulatory readiness and inspections.
Data Security:
Knowledge of data security and privacy regulations (e.g., GDPR, HIPAA) ensuring data privacy and security in lab operations and data management.
FDA and PMDA Device Regulations:
Knowledge of pre-market submissions, post-market surveillance, and QMS requirements for medical devices.
Client Relationship Management:
Experience as a strategic advisor for quality and regulatory interactions with pharmaceutical clients; managing client audits and aligning QMS with client expectations.
Team Leadership:
Proven ability to build and lead high-performing Regulatory and Quality teams; collaborate with Lab Operations, R&D, Clinical Affairs, and Legal.
Risk Management:
Experience in global regulatory risk assessments and mitigation aligned with QMS protocols.
Document Control:
Expertise in establishing and managing document control systems that keep quality and regulatory documents current 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 AI/ML-based systems experience.
Background in oncology, molecular diagnostics, or bioinformatics services with specific knowledge of AI/ML applications.
Deep expertise in CAP/CLIA and GCLP regulated environments; practical understanding of ICH, FDA, PMDA and EMA guidelines.
ISO 13485 for medical device QMS, EU IVDR, and other global regulatory requirements for SaMD/IVD a plus.
Track record managing audits from global pharmaceutical companies and acting as regulatory liaison for complex collaborations involving AI/ML.
Experience building and maintaining QMS and scalable regulatory infrastructure, with AI/ML validation in a diagnostic setting.
Seniority level : Not Applicable
Employment type : Full-time
Job function : Science, Quality Assurance, and Research
Industries : Biotechnology, Biotechnology Research, and Research Services
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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.
QMS Compliance:
Ensure the QMS meets and exceeds CAP/CLIA and GCLP standards, focusing on documentation, processes, and controls that support regulatory compliance and operational excellence.
QMS Maintenance and Improvement:
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.
Document Control:
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.
Regulatory Readiness:
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.
Global Regulatory Risk:
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.
Audits and Reviews:
Ensure client audits and regulatory reviews, especially those focused on quality management practices, are handled with precision and professionalism.
Partnership Expansion:
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.
Cross-Functional Collaboration:
Collaborate 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.
New Services and Markets:
Provide regulatory and QMS expertise on new service development, assay validation, and expansion into new markets or regulatory jurisdictions.
Preferred Skills
QMS Expertise:
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:
Ability to develop and lead regulatory strategies, ensuring compliance with CAP, CLIA, GCLP, and evolving industry regulations; experience with regulatory readiness and inspections.
Data Security:
Knowledge of data security and privacy regulations (e.g., GDPR, HIPAA) ensuring data privacy and security in lab operations and data management.
FDA and PMDA Device Regulations:
Knowledge of pre-market submissions, post-market surveillance, and QMS requirements for medical devices.
Client Relationship Management:
Experience as a strategic advisor for quality and regulatory interactions with pharmaceutical clients; managing client audits and aligning QMS with client expectations.
Team Leadership:
Proven ability to build and lead high-performing Regulatory and Quality teams; collaborate with Lab Operations, R&D, Clinical Affairs, and Legal.
Risk Management:
Experience in global regulatory risk assessments and mitigation aligned with QMS protocols.
Document Control:
Expertise in establishing and managing document control systems that keep quality and regulatory documents current 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 AI/ML-based systems experience.
Background in oncology, molecular diagnostics, or bioinformatics services with specific knowledge of AI/ML applications.
Deep expertise in CAP/CLIA and GCLP regulated environments; practical understanding of ICH, FDA, PMDA and EMA guidelines.
ISO 13485 for medical device QMS, EU IVDR, and other global regulatory requirements for SaMD/IVD a plus.
Track record managing audits from global pharmaceutical companies and acting as regulatory liaison for complex collaborations involving AI/ML.
Experience building and maintaining QMS and scalable regulatory infrastructure, with AI/ML validation in a diagnostic setting.
Seniority level : Not Applicable
Employment type : Full-time
Job function : Science, Quality Assurance, and Research
Industries : Biotechnology, Biotechnology Research, and Research Services
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