Job Title: Global Head of Quality Assurance
Location: Basel, Switzerland
Start Date: May – June (In Process)
Industry: Biotechnology (Cell and Gene Therapy)
Job Type: Full-time (2 days a week on-site)
About Us
We are an innovative biotech company based in Basel, Switzerland, specialising in developing cell and gene therapies for eye treatments (AAVP). As we move towards early access commercialisation, we are seeking a Global Head of Quality Assurance to lead our global quality strategy. This leadership role will ensure the highest standards throughout the product lifecycle.
Your Role
As the Global Head of Quality Assurance, you will:
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Lead Quality Strategy: Define and execute the global QA strategy, ensuring compliance with GMP, GCP, GLP, and other regulatory standards.
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Ensure Compliance: Oversee adherence to international regulations, including FDA, EMA, Health Canada, and MHRA.
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Manage Quality Systems: Implement a unified QMS to support both clinical and commercial phases.
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Product Quality: Oversee product quality from development to commercialisation.
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Lead Risk Management: Conduct global risk assessments and lead mitigation strategies.
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Build & Lead Teams: Build a global QA team and promote continuous improvement.
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Oversee Audits: Manage global audits and ensure readiness for regulatory inspections.
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Manage Vendors: Ensure external partners meet quality standards through audits.
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Ensure Documentation: Oversee CAPA, change control, and batch release processes.
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Collaborate Globally: Align quality practices with global teams across R&D, Manufacturing, and Clinical Operations.
What You’ll Need
We’re looking for someone with:
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Education: A Bachelor’s or Master’s in Life Sciences, Biotechnology, or a related field (PhD a plus).
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Experience: 12+ years in Quality Assurance, with 5+ years in global leadership for cell and gene therapies or biologics.
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Regulatory Knowledge: In-depth knowledge of GMP, GCP, GLP, and experience with FDA, EMA, and other regulatory bodies.
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Commercialisation Experience: Experience leading global commercialisation of gene or cell therapy products.
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Leadership: Proven ability to manage global teams and align stakeholders across regions.
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Strategic Thinking: Strong strategic focus on improvement and regulatory compliance.
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Communication Skills: Excellent verbal and written communication skills.
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Language Skills: Fluency in English required; German or French is a plus.
Additional Skills & Experience
You should also have:
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Expertise in QA for clinical and commercial settings, especially for cell and gene therapies.
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Experience managing complex, high-risk projects across global sites.
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Hands-on experience with QMS implementation and regulatory audits.
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Ability to thrive in a fast-paced, innovative biotech environment.
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Proactive problem-solving skills to address quality challenges.