Regulatory and Quality Control Implementation Lead

What we are looking for

As we prepare to engage more deeply with regulatory pathways across multiple jurisdictions, we are seeking a senior leader to own the quality and regulatory strategies, to help ensure that Nūmi’s science meets the proper standards and that our regulatory submissions are executed with precision and foresight. This role is mission‑critical for Nūmi’s development and path to market. As we build a first‑of‑its‑kind product category, ensuring robust quality framework and seamless implementation of regulatory strategy is central to our success. You will translate external regulatory counsel recommendations into actionable internal quality systems, coordinate cross‑functional requirements, and drive dossiers toward filings in key geographies by the end of 2026.

You will be a strategic driver and quality champion, ensuring that regulatory and quality practices are not merely compliant but optimized for speed, consistency, and innovation.

Key Responsibilities

Regulatory Implementation Ownership

• Partner closely with external regulatory counsel to interpret, operationalize, and implement all regulatory recommendations into internal practices.
• Create and maintain a detailed regulatory implementation roadmap supporting dossier preparation and filings across target regions.
• Track and report on regulatory milestones, risks, dependencies, and timelines to company leadership.

Quality Systems & Control

• Lead development, implementation, and continuous improvement of Nūmi’s Quality Management System (QMS) tailored to bioproduction and engineered biologics.
• Establish and maintain SOPs, document control, risk management, change control, and CAPA processes as appropriate for biotech scale‑up.
• Ensure internal readiness for inspections, audits, and verification activities aligned with regulatory expectations.

Cross‑Functional Leadership

• Collaborate with R&D, Bioprocess and Downstream process departments to ensure quality and regulatory considerations are integrated throughout discovery, scale‑up, and documentation generation.
• Serve as the internal ambassador for quality and regulatory expectations, aligning teams on timelines, deliverables, and compliance standards.

Documentation & Agency Readiness

• Own internal dossier content standards, templates, and knowledge repositories.
• Ensure regulatory documentation is inspection‑ready and aligned with agency requirements and filing expectations.
• Liaise with external counsel to prepare briefing packages, agency responses, and internal teams for engagements with regulatory bodies.

Innovation & Digital Tools

• Evaluate, pilot, and integrate novel AI‑enabled regulatory tools designed to accelerate dossier preparation, content generation, labeling compliance checks, change tracking, and regulatory intelligence.
• Partner with technical teams to ensure tools are deployed in ways that enhance regulatory quality outputs.

Experience & Knowledge

• BSc/MSc in a relevant field with 5+ years of experience in quality control or regulatory affairs within the biotech or food industry.
• Significant experience in quality control, quality systems, and regulatory implementation in biotech, biologics, or life‑science product environments.
• Deep understanding of quality frameworks (QMS, CAPA, change control) and working knowledge of relevant regulations (GMP, GLP, ISO frameworks).

Project & Process Leadership

• Strong project management skills, able to coordinate complex dossiers and implementation across teams.
• Ability to set priorities, drive execution, and report progress to stakeholders.
• Ability to work intricately across departments and prioritize multiple tasks in a fast‑paced startup environment.

Tech & Innovation Mindset

• Enthusiasm for exploring AI‑driven regulatory tools and digital solutions that accelerate quality and dossier preparation.

Benefits

• Competitive salary.
• Partial health insurance coverage.
• Partial transportation and lunch coverage.

EEO Statement

Nūmi is committed to building a diverse and inclusive workplace. We welcome applications from people from all walks of life.