Quality Manager

About the role

The Quality Manager will lead the development, implementation and continuous improvement of the company’s quality framework across the entire product lifecycle. This hands‑on, strategic position supports a fast‑paced biotech environment focused on innovative cancer and fibrotic disease therapies.

Key responsibilities

• Develop and execute the organisation’s quality strategy aligned with product development, clinical studies and commercialisation.
• Design, implement and maintain a Quality Management System (QMS) compliant with ISO, cGMP, ICH and other global standards.
• Act as the authority on quality matters, providing guidance to senior management and the Board.
• Plan, coordinate and facilitate internal, supplier and regulatory audits, ensuring timely resolution of findings.
• Build and oversee the CAPA system and change‑control processes, ensuring effective root‑cause analysis and corrective actions.
• Lead quality risk‑management activities following ICH Q9 and ISO 14971 principles.
• Partner with R&D, manufacturing, clinical, regulatory and commercial teams to embed quality requirements.
• Design and deliver quality training programmes and present metrics and strategic updates to senior leadership.

Required profile

• Tertiary qualification in life sciences, medical technology, biomedical engineering or a related field.
• Minimum 5 years experience in a quality management role within biotech, diagnostics, pharmaceutical or medical‑device industry.
• Proven experience implementing, maintaining and improving a QMS in a regulated environment.
• Track record of achieving or maintaining certifications such as ISO 9001:2015 and cGMP.
• Strong knowledge of global quality and regulatory standards (ISO 9001, ISO 14971, cGMP, ICH).
• Experience managing audits, CAPA, document control and change‑control processes.

Required skills

• ISO 9001:2015
• ISO 14971
• cGMP
• ICH guidelines (including Q9)
• QMS implementation
• CAPA management
• Audit management
• Change‑control processes
• Risk‑management methodology