QA Operations CGT Teamlead (Cell & Gene Therapy)

Location: Geleen, The Netherlands

Annual base salary: €54,000–€75,600

Company

hirify.global operates globally connected life-science manufacturing sites focused on producing medicines and therapies.

What you will do

• Lead, coach, develop, and support the recruitment of QA professionals.
• Plan and oversee daily QA Operations activities, including batch record review, deviations, CAPA, change controls, and product disposition.
• Ensure manufacturing and quality documentation comply with cGMP regulations, quality agreements, internal procedures, and global quality standards.
• Serve as the primary QA contact for Cell & Gene Therapy manufacturing and collaborate with manufacturing, supply chain, regulatory affairs, and other departments.
• Lead quality investigations, root cause analysis, risk assessments, audits, and regulatory inspection responses.
• Monitor quality metrics, identify trends, and drive continuous improvement.

Requirements

• Bachelor’s or master’s degree in biotechnology, biochemistry, pharmacy, chemistry, or a related scientific discipline.
• At least five years of Quality Assurance experience in a cGMP-regulated environment, including at least two years in a leadership or supervisory role.
• Strong understanding of Cell & Gene Therapy manufacturing processes and related quality requirements.
• In-depth knowledge of cGMP regulations, including relevant FDA and EMA requirements, and quality management systems.
• Fluency in written and spoken English, with strong communication, analytical, planning, and decision-making skills.
• Experience with electronic quality management systems is preferred.

Culture & Benefits

• Full-time employment in an agile and dynamic working culture.
• Inclusive and ethical workplace with a focus on collaboration, accountability, excellence, passion, and integrity.
• Performance-oriented compensation programs.
• Benefits vary according to role and location.