Job summary
Job post source
This job is directly from BostonGene
Job overview
The Head of Quality Assurance & Regulatory Affairs at BostonGene leads regulatory strategy and quality management for the company's molecular laboratory, focusing on compliance and AI/ML integration to support precision medicine.
Responsibilities and impact
The role involves designing and implementing a Quality Management System (QMS), ensuring compliance with CAP/CLIA and GCLP standards, managing regulatory strategies and client audits, leading a quality and regulatory team, and collaborating with senior leadership across departments.
Experience and skills
Requires 10+ years in regulatory affairs and quality leadership in biotech or clinical diagnostics, expertise in CAP/CLIA, GCLP, FDA, PMDA regulations, experience with AI/ML systems, and strong client management skills; advanced degree preferred.
Work environment and culture
BostonGene values innovation in precision medicine, fostering a quality-driven culture with cross-functional collaboration and leadership engagement.
Company information
BostonGene is a precision medicine company using AI-powered multiomic profiling to advance drug development and clinical decision-making, with a CLIA-certified, CAP-accredited lab and partnerships with pharma and cancer centers.
Team overview
The candidate will lead a high-performing Regulatory and Quality team, working closely with Lab Operations, R&D, Clinical Affairs, and Legal teams to implement quality and compliance strategies.
Unique job features
The role uniquely combines regulatory leadership with AI/ML validation in diagnostics, managing compliance in a cutting-edge molecular lab environment with global pharma collaborations.
Company overview
BostonGene is a biotechnology company specializing in advanced cancer research and precision medicine. They leverage cutting-edge genomic and transcriptomic analysis to develop personalized treatment plans for cancer patients, aiming to improve outcomes through data-driven insights. Founded in 2015, BostonGene has rapidly grown by partnering with leading medical institutions and integrating AI-driven technologies to enhance their diagnostic and therapeutic capabilities. Their revenue model includes collaborations with healthcare providers, licensing their proprietary technology, and offering comprehensive genomic profiling services.
How to land this job
Position your resume to highlight leadership in Quality Assurance and Regulatory Affairs, emphasizing your experience with CAP/CLIA and GCLP compliance in clinical or biotech laboratory settings.
Focus on showcasing your expertise in developing and managing Quality Management Systems (QMS), regulatory strategy, and client-facing roles involving pharmaceutical partnerships, especially with AI/ML-based diagnostic technologies.
Apply through BostonGene's corporate careers page, LinkedIn, and other biotech job boards to maximize your chances of being noticed by multiple recruiters.
Connect with current BostonGene employees in Regulatory Affairs, Quality Assurance, or Lab Operations on LinkedIn, using ice breakers like commenting on recent BostonGene innovations in AI-powered diagnostics or asking about their approach to regulatory challenges in molecular diagnostics.
Optimize your resume for ATS by incorporating keywords such as 'Quality Management System,' 'CAP/CLIA,' 'GCLP,' 'regulatory strategy,' 'AI/ML validation,' 'FDA,' 'PMDA,' and 'pharmaceutical audits' to ensure it passes automated screenings.
Use Jennie Johnson's Power Apply feature to automate tailored applications across platforms, identify relevant LinkedIn contacts for networking, and ensure your resume is optimized for ATS, freeing you to focus on interview preparation and strategic networking.
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