Director Of Quality

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 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. 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 #J-18808-Ljbffr