Head of Quality Control

Job Description

Solvias helps innovative companies advance their path to commercialization with analytical solutions powered by deep scientific expertise and a relentless focus on our customers’ success. Cergentis, one of the Solvias sites, is a leading provider of high-end genetic QC solutions, located at the Utrecht Science Park in The Netherlands. Based on our proprietary and widely published Targeted Locus Amplification (TLA) technology platform, our solutions are considered as the gold standard for the genetic characterization and quality control of genetically engineered cell lines, immunotherapy products and animals. We routinely support all leading pharma, biotech and academia globally in the fields of genome editing, biopharmaceutical drug development, cell and gene therapy and genetically engineered (animal) models.

Currently, we are looking for a Head of Quality Control twith multiple years of experience in working in a GMP environment, to lead our expanding QC department and drive the company’s growth and ambition.

The QC department is responsible for processing all analyses in our service portfolio from wet-lab work to analysis. Including, but not limited to, our TLA technology, NGS and ddPCR. To provide our customers with the highest quality data, we are currently working according to ISO17025 standards, while being in the process of implementing GMP. Within the team, we are working on continuous improvement according to LEAN Six Sigma.

Key Responsibilities

• Lead the QC department, currently 12 members and growing.
• Develop and maintain analytical documentation in alignment with ISO17025 standards and GMP requirements.
• Ensure a QC way of work in compliance with ISO17025 standards and GMP requirements.
• Drive continuous improvement using LEAN Six Sigma methodologies.
• Oversee operation to ensure timely, complete and correct delivery of customer reports.
• Ensure all analytical processes, metrics, and departmental goals are met.
• Oversee Root Cause Analyses (RCAs) and CAPA management.
• Act as the primary QC contact for internal, external, and regulatory inspections.
• Manage, hire, and develop team members, ensuring comprehensive training.
• Participate as a key member of the Leadership Team.

Requirements

• PhD in Molecular Biology or a related field
• Minimum of 10 years of experience in Quality Control in a biotech, pharma, or closely related company, with a minimum of 3 years of proven leadership experience.
• Extensive knowledge of FDA and EMA regulatory requirements and guidelines applicable to biologics or pharmaceuticals.
• Proficiency in molecular biology techniques such as PCR, NGS, and ddPCR.
• Strong communication and stakeholder management skills.
• Flexible team player who is fluent in English and self-driven.
• Strong organizational skills with the ability to prioritize and manage complex projects.

 

Benefits

Working at Cergentis means working in an international and exciting environment with opportunities to grow and accelerate your career. We are a young and dynamic team of talented people from all over the world. Our company culture is best described as informal – where hard work and team spirit are considered very important. We offer a responsible job in a fast-growing company where you will have the chance to make an impact.

Interested? Please apply below before June 31, 2024.

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