Our client, a renowned leader in the field of immunotherapy, dedicated to pushing the boundaries of science to transform the lives of patients is currently seeking a highly experienced and strategic QA Manager to lead their QA efforts.

Key Responsibilities

• Quality Strategy: Develop and implement a comprehensive quality strategy aligned with the company’s goals and regulatory requirements.
• Regulatory Compliance: Ensure full compliance with national and international regulatory standards, including GxP and ISO requirements.
• Quality Systems: Oversee and maintain the quality management system, including document control, CAPA, change control, and risk management.
• Quality Audits: Plan and execute internal and external audits, identifying areas for improvement and ensuring adherence to quality standards.
• Supplier Quality: Manage supplier quality through supplier audits, evaluation, and compliance monitoring.
• Team Leadership: Lead and mentor a team of QA professionals, fostering a culture of continuous improvement and compliance within the organization.
• Quality Metrics: Establish and monitor key performance indicators (KPIs) related to quality, providing insights to senior management.
• Quality Training: Develop and deliver training programs to enhance the quality awareness of employees and ensure understanding of quality policies.

Qualifications

• Bachelor’s or Master’s degree in a relevant life sciences discipline.
• Minimum of 6 years of experience in quality assurance, with a preference for expertise in biotech and immunotherapy.
• In-depth knowledge of regulatory requirements in the biotech and immunotherapy sectors, including GMP and ISO standards.
• Strong leadership and team management skills.
• Excellent analytical, problem-solving, and communication skills.
• Proven experience in leading quality initiatives and implementing quality systems.
• Quality auditor certification is a plus.

Can this be interesting for you or anyone you know? If so, please apply here or contact Conor Kelly with your number/CV ASAP and he will give you a call.

• : +41 (0) 44 5514 407
• : [email protected]