Quality Officer (Fractional)

Brooklyn Health • Brooklyn, NY

1d

About The Position

About this role Brooklyn Health is seeking a Quality Officer to join us in a fractional capacity (10–20 hours per week). While we are a lean team, we maintain a robust Quality Management System (QMS) built on deep regulatory expertise. As we scale, we require a dedicated leader to evolve our quality infrastructure, drive day-to-day QA excellence, and serve as the primary lead for customer audits. This role is critical in allowing our product and engineering teams to remain focused on innovation while ensuring our platform meets the highest standards of the life sciences industry. About Brooklyn Health Brooklyn Health is solving the measurement problem in mental health through accurate, objective and sensitive measurement of symptoms, enabling precision neuroscience in clinical research and patient care. Through digital phenotyping and AI-powered clinical assessments, our Willis eCOA platform is modernizing the technology stack for CNS clinical trials, improving endpoint quality and reducing placebo response. Brooklyn Health’s approach builds trust through open-source methods and scales them through proprietary technology for commercial application. Based in Brooklyn, New York, Brooklyn Health is backed by leading healthcare and technology investors including HealthX Ventures, Metrodora Ventures, Story Ventures, RiverPark Ventures, Laconia Capital, Everywhere Ventures and others. For more information, visit www.brooklyn.health .

Requirements

• Audit Veteran: Proven track record leading clinical trial vendors through successful CRO and Sponsor audits.
• SME in Regulatory Frameworks: Deep expertise in 21 CFR Part 11, Good Clinical Practice (GCP), and GxP environments.
• Privacy Knowledge: Strong command of data privacy regulations, including HIPAA and GDPR, specifically as they apply to SaaS and cloud-based health tech.
• Tech-Forward Mindset: Comfortable working with modern cloud infrastructure and agile software development life cycles (SDLC).
• Communication: Ability to translate complex regulatory requirements into actionable steps for technical and non-technical stakeholders.

Responsibilities

• QMS Governance: Own the maintenance and continuous improvement of the Quality Management System (QMS) to ensure it remains "fit for purpose" as the company scales.
• Audit Leadership: Serve as the primary point of contact and lead for Sponsor and CRO audits, managing the process from prep to post-audit CAPA (Corrective and Preventive Actions) if required.
• Regulatory Compliance: Ensure ongoing adherence to 21 CFR Part 11, GCP, and ISO standards where applicable.
• Operational QA: Execute routine quality workflows, including risk assessments, user access reviews, and security exercises.
• Validation Oversight: Provide guidance and oversight for Computer System Validation (CSV) efforts to ensure software products meet rigorous regulatory expectations.
• Training & Culture: Manage the training lifecycle for employees and contractors, fostering a culture of "quality by design" across the organization.

What This Job Offers

• Job Type: Part-time
• Career Level: Mid Level
• Education Level: No Education Listed