Pioneering the Future of Personalized Regenerative Medicine

Help Us Build the Future of Regenerative Medicine

Our Client transforming how severe skin injuries are treated through personalized regenerative therapies. Their pioneering bioengineered skin technology is at the forefront of innovation — and now, they are strengthening foundations to prepare for the next growth phase.

We are seeking a Manager or Senior Manager Quality Assurance — a hands-on quality expert with proven leadership experience, ready to roll up their sleeves, make an impact, and evolve alongside a cutting-edge biotech environment.

Mission

As QA Manager/Senior Manager, you will play a critical role in maintaining and enhancing our Quality Management System (QMS) to meet GMP and ISO 13485 standards. You’ll also lead key quality processes and guide team members as we scale our operations. This role combines technical excellence, regulatory know-how, and team coordination, in a context that values agility, pragmatism, and scientific purpose.

Core Responsibilities

Quality Leadership

• Maintain and improve QMS to ensure compliance with GxP and ISO 13485.
• Lead day-to-day QA operations: deviations, CAPA, change control, documentation, and release processes.
• Support inspection readiness, internal audits, and risk assessments.
• Contribute to validation and tech transfer documentation.

Team & Cross-Functional Coordination

• Provide guidance to junior QA colleagues, consultants, or interns.
• Act as a QA partner to Manufacturing, Clinical, and Regulatory teams.
• Support communication with regulatory authorities (Swissmedic, EMA).
• Bring a solution-driven mindset to daily operations and scale-up needs.

Your Profile

• 6–10 years of experience in QA roles within biotech, ATMPs, or medical devices
• Proven ability to manage or mentor team members, even in a small structure
• In-depth knowledge of GMP, GDP, and ISO 13485
• Strong documentation and communication skills; fluent in English
• Comfortable in a dynamic, fast-growing, and hands-on environment
• Motivated by a mission-driven company making a real difference for patients

Why Join ?

Science with Purpose: Work on regenerative therapies that could transform patient lives

Agility & Impact: Be part of a company where your voice matters and your actions shape the future

Collaborative Culture: Join a multidisciplinary team that shares commitment, curiosity, and integrity

Room to Grow: Step into a high-potential role with increasing responsibility as the company scales