Director of Quality and Compliance

OmniScience is a leading AI organization focused on transforming clinical trials through Vivo, the first agentic AI control tower that unifies data and delivers real-time, explainable insights. By integrating complex trial data into a single platform, OmniScience helps clinical trial teams make faster, evidence-based decisions. We are driven by the mission to help trial teams act faster, reduce costs, and bring life-changing treatments to patients sooner.

Job Description

Forward thinking Information Security and Quality Management System leader who is able to navigate global compliance requirements and ensure a right-sized approach for the management systems of OmniScience.

Primary Responsibilities

→ Quality Management

• Drive continuous improvement of OmniScience’s Quality Management System (ISO 9001) through regular management reviews, internal audits, and data-driven quality metrics, ensuring processes remain measurable and functioning as intended.
• Lead the creation, improvement, and lifecycle management of standard operating procedures and other controlled documentation required to maintain a compliant, audit-ready Quality Management System.
• Own the corrective and preventive action (CAPA) program, ensuring thorough root cause investigation and the effective, timely implementation of corresponding actions.
• Lead Quality Risk Management throughout OmniScience, partnering with teams across the business to embed a proactive, risk-minded philosophy into everyday operations.
• Manage Omni’s training program and lead all audits, inspections, and questionnaire/RFI engagements, serving as the primary point of contact for regulators, customers, and certification bodies.

→ Computer System Validation

• Own and continuously mature Omni’s GAMP5 Computer System Validation (CSV) program, ensuring compliance with GAMP 5 and 21 CFR Part 11.
• Review and ensure CSV approaches align with the FDA’s Computer Software Assurance (CSA) guidance, applying risk-based, critical-thinking principles to right-size validation effort.
• Establish and maintain validation deliverables—including validation plans, requirements, test protocols, and traceability—across the full system lifecycle.
• Ensure electronic records and electronic signatures meet data integrity and ALCOA+ expectations throughout all validated systems.
• Partner with engineering, IT, and vendors to assess and qualify new and changed systems, and to keep systems in a validated state through robust change control.

→ Information Security

• Drive continuous improvement of OmniScience’s Information Security Management System (ISO 27001) through regular reviews, internal audits, and ongoing management of certification.
• Maintain and evolve the information security risk assessment and treatment process, ensuring risks are identified, prioritized, and mitigated to an acceptable level.
• Develop, maintain, and enforce information security policies, standards, and controls aligned with recognized frameworks and applicable regulatory requirements.
• Oversee security incident response and reporting, ensuring events are detected, contained, investigated, and remediated in a timely manner.
• Promote a security-aware culture across Omni through training, awareness initiatives, and close collaboration with engineering and IT teams.

→ AI

• Align ISO 9001 and ISO 27001 with AI management frameworks (e.g., ISO 42001, NIST AI RMF) to deliver a single, unified approach to management systems across Omni.
• Drive and support responsible AI governance, enabling the safe, ethical, and compliant adoption of AI across the organization.
• Develop and maintain AI management policies, procedures, and systems that operationalize governance requirements in day-to-day practice.
• Monitor evolving AI regulations and standards (e.g., the EU AI Act) and translate them into actionable internal requirements.
• Partner with product and engineering teams to embed AI risk management and oversight into the development lifecycle.
• Leadership & Strategic Alignment
• Communicate and partner with executive leadership to ensure Omni’s goals and vision are aligned with, and supported by, the Quality and Information Security Management Systems.
• Serve as the organization’s primary subject matter expert and trusted advisor on regulatory, quality, and compliance matters.
• Provide regular, clear reporting to leadership on the health, performance, and risk posture of the management systems.
• Build, mentor, and lead a high-performing regulatory, quality, and compliance function as the organization scales.
• Champion a culture of quality, compliance, and continuous improvement across all levels of the organization.

Experience

• 3-5yrs working in Regulatory, Quality, and Compliance for software, pharmaceutical, or medical device
• Working knowledge of Software Development Lifecycles, including Security, Quality and Privacy by design principles, Agile process, QA testing.
• Subject Matter Expert in ISO Standards, including ISO 9001, ISO 13485, ISO 27001, ISO 42001
• Subject Matter Expert with global Health Authority Regulations: 21 CFR part 11, 820, ICH E6(r3), ICH Q10, PIC/S,
• Awareness and working knowledge of HIPAA and NIST 800-53
• Awareness and working knowledge of EU CRA, EU AI ACT, GDPR, CCPA
• Awareness and use of AI systems (Claude, ChatGPT, Gemini), and understanding of how they work (LLMs, MCPs, APIs, etc.)
• Facilitate and Support audits and inspections
• Excellent verbal and written communication skills, with curiosity and a willingness to learn

Full time role, remote, must reside in U.S.