Regulatory and Quality Control Implementation Lead at Nūmi

Paris, Ile-de-France, France -

Full Time

Start Date

Immediate

Expiry Date

27 May, 26

Salary

0.0

Posted On

26 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management System (QMS), Regulatory Implementation, SOPs, Document Control, Risk Management, Change Control, CAPA Processes, Bioproduction, Engineered Biologics, Regulatory Submissions, Dossier Preparation, Project Management, Cross-Functional Leadership, Regulatory Intelligence, AI-Enabled Tools, Biotech Scale-up

Industry

Biotechnology Research

Description

About Nūmi 🚀 Nūmi is a bioproduction platform harnessing human mammary cells to produce key ingredients with proven health benefits across all stages of life. More specifically, it is the first European cultivated breast milk company aiming to produce human milk constituents to better match the ideal nutrition for babies! We are an early-stage, VC-backed biotech based in the heart of Paris (Hôpital Cochin, Paris 14th) and supported by world-class investors and scientific partners. ⚖️ Nūmi's Values ☀️Positivity : At Nūmi, we cultivate positivity every day. Our mission drives us to communicate with passion and energy, always keeping the bigger impact in sight. We celebrate quick wins, but never lose track of our ultimate goal. 🤸Excellence : At Nūmi, excellence starts with dedication and a commitment to constant improvement. We embrace challenges as opportunities to learn and push ourselves to deliver high-quality results. Through effort, attention to detail, and integrity, we grow both individually and collectively as a team. 💙 Team-Work and Pedagogy : At Nūmi, we believe that teamwork makes us stronger. We encourage knowledge-sharing, open feedback, and mutual respect. Each Nūmiz is here to lift others up, ensuring that the collective succeeds. 🚀 Ambition : At Nūmi, we set ambitious goals and challenge ourselves to think big. Nūmi is driven by bold ideas and relentless determination, always aiming for the stars to create real impact. 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 quality and regulatory implementation, helping ensure that Nūmi’s science meets the highest 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 control 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 implementer and quality champion, ensuring that regulatory and quality practices are not merely compliant but optimized for speed, consistency, and innovation. Key Responsibilities🎯 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 (e.g., risk assessments, mitigation plans), change control, and CAPA processes as appropriate for biotech scale-up. Ensure internal readiness for inspections, audits, and verification activities aligned with regulatory expectations (e.g., FDA, EMA, ANSM, other target agencies). 📄 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 (e.g., EU, US, other geographies). Track and report on regulatory milestones, risks, dependencies, and timelines to company leadership. 🤝 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 (e.g., biology, chemistry, food science, or related disciplines) 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 (e.g., GMP, GLP, ISO frameworks as relevant). 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. Recruitment process Initial skills matching and review of your background. First interview with our cofounder and CTO Eugénie. A technical case study to assess your understanding of quality control and regulatory frameworks. A last interview on-site to meet part cofounder and CEO Eden, part of the team and discuss your experience and insights. Nūmi is committed to building a diverse and inclusive workplace. We welcome applications from people from all walks of life. 🚀 Unique opportunity to be one of the first employees at an early stage biotech company, shaping the future of nutrition. 💥 Growth opportunities: you will have the opportunity to grow and develop with the company. 🔬 Access to top-quality facilities, research services and infrastructure. 💰 Competitive salary, part health insurance coverage, part transportation and lunch coverage. ⭐ Employee first mentality, we prioritize the well-being of our team members, both in terms of their mental and physical health.

Responsibilities

This senior leader will own the implementation of quality and regulatory strategy, translating external counsel into actionable internal quality systems and driving dossier preparation for filings across key geographies by the end of 2026. Key duties include leading the development of the Quality Management System (QMS), operationalizing regulatory recommendations, and ensuring cross-functional alignment on compliance standards.