Medior Quality Engineer, Leiden, Zuid-Holland

The Company
The client is part of the global pharmaceutical company. The facility is focused on the development and manufacturing of biologic medicines, particularly in the fields of immunology, oncology, and infectious diseases. They specialize in producing large-scale biologic drugs, which are typically made from living cells and are used to treat complex diseases. 

Role Description
The Junior Quality Engineer is responsible for leading and coordinating investigations related to quality issues within manufacturing processes, systems, and products. The role focuses on identifying root causes, ensuring effective corrective and preventive actions (CAPA), and maintaining compliance with internal standards and regulatory requirements. Working cross-functionally with operations and quality teams, the Quality Engineer drives continuous improvement, ensures accurate documentation, and communicates outcomes to key stakeholders. This position requires strong analytical capabilities, attention to detail, and the ability to manage complex investigations with a high level of independence and professionalism.

Responsibilities

• Leading and managing quality investigations, including non-conformances, CAPAs, and change controls, from initiation through completion.
• Applying in-depth knowledge of quality regulations and standards to support the handling and closure of quality records.
• Assembling and guiding cross-functional teams for investigation activities and ensure timely escalation of risks and issues.
• Reviewing and approving documentation related to operational processes and product quality.
• Maintaining and updating procedures and quality documentation in line with regulatory requirements, audit outcomes, and internal findings.
• Ensuring accurate, compliant, and timely completion of all quality records.
• Initiating and implementing risk mitigation strategies and continuous improvement initiatives with limited supervision.
• Supporting formal escalation processes to ensure visibility and management of risks impacting safety, product quality, and compliance.
• Conducting regular GEMBA walks to assess adherence to GMP standards, identify opportunities for improvement, and supporting implementation of corrective actions.
• Communicating effectively with stakeholders, maintaining professionalism, discretion, and sound judgment in all interactions.

Requirements

• Bachelor’s degree (HBO level) in a relevant field, with a minimum of 5 years’ experience in a Quality Engineering, investigation lead, or similar role within the pharmaceutical industry.
• Proficiency in English at a minimum B2 level.
• Strong computer skills: intermediate proficiency in MS Office, working knowledge of data analysis, and advanced use of relevant business applications.
• Demonstrated ability to work both independently and collaboratively in a cross-functional environment.
• Highly organized, proactive, and decisive, with strong accountability for outcomes.
• Excellent analytical and problem-solving skills, including the ability to manage complexity, analyze data, identify root causes, and develop effective solutions.
• Strong attention to detail and commitment to quality standards.
• Ability to manage multiple priorities and perform under pressure while maintaining high-quality output.
• Flexible and adaptable in a dynamic environment with changing priorities.
• Effective stakeholder management skills, with the ability to build strong working relationships and maintain alignment.

Other information  
Apply to our vacancy for more information. Looking forward to getting in touch!  

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