Director of Quality

vor 1 Tag

Zürich, Zürich, Schweiz W Talent Vollzeit

Direct message the job poster from W Talent

Senior Equity Partner - Healthcare & Life Sciences @ W Talent | Strategic Talent Acquisition consulting

Pioneering the Future of Personalized Regenerative Medicine

Our client is transforming lives through innovation in personalized skin regeneration therapies. As a leading biotech company, their mission is to bring advanced therapies to patients suffering from severe skin injuries and diseases. The groundbreaking bioengineered skin technology aims to revolutionize the field of regenerative medicine, making a lasting impact on global healthcare.

To drive our next phase of growth, we are looking for a (Senior) Director Quality—a visionary leader who thrives in a fast-paced, high-stakes biotech environment and is eager to shape the future of advanced therapies.

The Challenge & Opportunity

As (Senior) Director Quality, you will be at the forefront of building and optimizing a best-in-class Quality Management System (QMS) that aligns with GMP, GDP, GCP, and ISO 13485 standards. You will lead quality initiatives across clinical development, manufacturing, and regulatory compliance, ensuring seamless tech transfers and validation processes.

This is a critical leadership role in a high-growth, innovative company, requiring a hands-on, problem-solving approach to drive excellence, support regulatory inspections, and embed a strong quality culture across the organization.

You won't just oversee quality—you will build it, scale it, and optimize it.

Key Responsibilities

  1. Quality & Compliance Leadership
    • Define and implement a strategic vision for Quality, ensuring alignment with mission and regulatory landscape.
    • Lead the end-to-end development of the Quality Management System (QMS), ensuring compliance with GMP, GDP, GCP, and ISO 13485.
    • Spearhead quality metrics, risk management, and continuous improvement initiatives to enhance compliance and operational efficiency.
    • Own the GMP certification process, collaborating with regulatory authorities such as Swissmedic, EMA, and FDA.
    • Drive supplier qualification, audits, CAPA management, and regulatory inspections.
    • Build, mentor, and inspire a high-performance Quality team.
    • Instill a proactive, solution-driven quality mindset throughout the company.
    • Collaborate cross-functionally with R&D, Manufacturing, Clinical, and Regulatory teams to ensure seamless quality integration.
  2. Operational Excellence in a High-Growth Environment
    • Lead process validation, tech transfers, and GMP manufacturing readiness.
    • Ensure inspection readiness for health authorities and internal audits.
    • Provide expert guidance on risk management, deviations, change control, and compliance strategies.
    • Take an agile, problem-solving approach to address quality challenges in a rapidly evolving biotech landscape.

What You Bring:

Expertise & Leadership:

  • 12+ years of Quality leadership experience in pharmaceuticals, biotech, or medical devices.
  • Proven success in GMP, GCP, GDP, and ISO 13485 compliance.
  • Strong knowledge of Swissmedic, EMA, and FDA regulatory requirements.

Strategic & Hands-On Mindset:

  • Thrives in a high-growth, fast-paced biotech startup.
  • Hands-on problem solver with a "get it done" attitude.
  • Proven ability to lead quality transformations and build scalable systems.

Collaboration & Adaptability:

  • Ability to work in a dynamic, evolving environment where agility is key.
  • Effective communicator, able to align stakeholders and drive decision-making.
  • Entrepreneurial mindset with a passion for innovation and patient impact.

Technical & Regulatory Mastery:

  • Expertise in biotech manufacturing, cell & gene therapy, or regenerative medicine.
  • Experience in process validation, tech transfer, and supplier qualification.
  • A proactive approach to continuous improvement and risk management.

Why Join ?

Shape the Future of Regenerative Medicine – Work on pioneering therapies that will redefine personalized medicine.

High-Impact Leadership Role – Own the quality vision and make strategic decisions in a cutting-edge biotech company.

Fast-Paced, Agile Environment – Join a high-growth, ambitious biotech where your expertise directly drives innovation.

Collaborative, Entrepreneurial Culture – Be part of a team that values excellence, adaptability, and scientific breakthrough.

Seniority level
  • Director
Employment type
  • Full-time
Job function
  • Quality Assurance, Research, and Production
  • Industries: Pharmaceutical Manufacturing and Biotechnology Research
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