Quality Management Specialist

An innovative, clinical-stage biotechnology organization focused on developing gene- and cell-based therapies for serious diseases is seeking an experienced QMS Manager . This role offers the opportunity to play a pivotal part in strengthening and evolving the Quality Management System within a highly regulated, cutting-edge biotech environment.

The QMS Manager will be responsible for overseeing, maintaining, and continuously improving the Quality Management System to ensure compliance with global regulatory requirements. The role will work closely with R&D, Clinical, Manufacturing, Regulatory Affairs, and external partners to support development and commercialization activities.

Key Responsibilities

• Own and manage the Quality Management System in compliance with applicable regulations and standards (e.g. GMP, GxP, ISO standards).
• Develop, implement, and maintain quality policies, procedures, and controlled documentation.
• Manage QMS processes including deviations, CAPAs, change control, risk management, and training.
• Lead internal audits and support health authority and partner audits and inspections.
• Oversee document control systems and ensure training compliance across the organization.
• Ensure effective quality oversight of external vendors, CMOs, and partners.
• Monitor quality performance metrics and report QMS status to senior management.
• Promote a culture of quality, compliance, and continuous improvement across the company.

Required Experience & Qualifications

• Bachelor’s degree in Life Sciences, Biotechnology, Pharmacy, or a related discipline.
• Significant experience managing a QMS within a biotech, pharmaceutical, or advanced therapy environment.
• Strong knowledge of GMP, GxP, and relevant international regulatory requirements.
• Proven experience supporting regulatory inspections and audits.
• Hands‑on experience with electronic QMS (eQMS) platforms.
• Excellent organizational, communication, and stakeholder management skills.
• Experience in gene therapy, cell therapy, or advanced therapy medicinal products (ATMPs).
• Experience working in a clinical-stage or growing biotech company.