Head of Ops (m/w/d) – Diagnostics | Hamburg, Hybrid

M2Talents; Hamburg; Híbrido; EUR 70 000 - 100 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Leadership exposure

Hybrid work model in Hamburg

Resumo da oferta

M2Talents is recruiting for an established Hamburg company driving diagnostics, offering a leading role in scaling its global healthcare platform. You will own quality, regulatory affairs, procurement and logistics, shaping processes as the ERP system is replaced and the future supply chain is designed.

With about five years’ relevant experience and fluency in English, you’ll lead one logistics and order-processing colleague plus junior support, in a hybrid Hamburg-based position offering high

Qualificações

• Strong Quality Management and Regulatory Affairs experience in healthcare or regulated environments.
• Procurement and supply chain experience including forecasting, suppliers, inventory and availability.
• ERP and operational process experience.
• Autonomous, structured, hands-on approach with pragmatic decisiveness.
• Strong communicator with intercultural competence and stakeholder management.
• English at C1; around five years of relevant experience.

Responsabilidades

• Own and continuously improve the Quality Management System and Quality Manual.
• Maintain regulatory documentation for devices, tests and suppliers (IVDR Class A).
• Lead on product-quality issues and supplier escalations, deciding on pauses or recalls.
• Take ownership of procurement and supply chain: forecasting, availability, inventory and working-capital on short shelf-life products.
• Manage supplier relationships and keep product cost under control.
• Shape the logistics setup as the company scales, including 3PL considerations.
• Lead ERP replacement efforts.
• Lead one experienced logistics and order-processing colleague plus junior support.

Conhecimentos

Quality Management

Regulatory Affairs

Procurement

Supply Chain

ERP

Stakeholder Management

Ferramentas

ERP systems

Descrição da oferta de emprego

The opportunity

Our client is an established Hamburg company that has shifted its focus fully into diagnostics. It handles the global commercialisation of a professional point-of-care platform for rapid blood testing, an open system that reads tests from several manufacturers and is used by doctors, pharmacists and practitioners. The German launch is a year behind them, hundreds of sites are already onboarded, and international distribution has begun. Around 20 people, privately backed, and scaling.

Why this one stands out

• Up to €100,000 per year for the right profile, plus bonus
• A seat on the leadership team with direct exposure to management
• Three functions under one remit, with scope to grow toward a Head of Operations position
• A build role, not an administer role: structures and processes are yours to shape
• Lead role in replacing the ERP system and designing the future logistics setup
• Preventive healthcare and longevity, at the point the company scales internationally
• Permanent, full-time, hybrid in Hamburg with around one home-office day a week

What you'll do

• Own and continuously improve the Quality Management System and Quality Manual, and make sure processes are followed in practice
• Maintain regulatory documentation for devices, tests and suppliers. The device is IVDR Class A; individual tests can sit in higher classes depending on the biomarker
• Lead on product-quality issues and supplier escalations, deciding with commercial stakeholders when a product is paused or recalled
• Take overall ownership of procurement and supply chain: forecasting, availability, inventory and working-capital exposure on short shelf-life products
• Manage supplier relationships and keep product cost under control
• Shape the logistics setup as the company scales, including when to move fulfilment to a 3PL
• Play a leading role in replacing the ERP system
• Lead one experienced logistics and order-processing colleague plus flexible junior support

What you bring

• Strong Quality Management and Regulatory Affairs experience in healthcare, medical devices or a comparably regulated environment. This is the hard requirement
• Supply chain and procurement experience broad enough to own forecasting, suppliers, inventory and availability
• ERP and operational process experience
• Able to work autonomously and make decisions from day one: highly structured, but pragmatic and hands-on
• Strong communicator and stakeholder manager, interculturally competent
• English C1. Around five years of relevant experience is a guideline, not a cut-off

Nice to have:

IVD or diagnostics exposure, work with biomarkers or diagnostic tests, building processes in a start-up, scale-up or SME, ERP implementation or migration, scaling or outsourcing logistics, German, Russian.

Please note:

this is a hands-on scale-up remit. Candidates looking for a large team or a narrow, highly specialised corporate QA/RA role are unlikely to be a fit.

Process:

intro call with M2Talents, initial interview on background and motivation, technical interview on quality, regulatory and supply chain, then final interview and decision with senior management.