Sr. Quality Engineer, Leiden, Zuid-Holland

The Company
We are a leading global healthcare organization, committed to developing innovative therapeutics and advancing scientific research. Our teams operate in a multidisciplinary environment to ensure high-quality, safe, and effective products that make a real difference in patients’ lives.

Role Description
 As a Senior Quality Engineer, you will lead quality assurance activities within the Project Execution organization. You will ensure that processes meet regulatory standards, support continuous improvement initiatives, and drive high-quality outcomes across operations. Acting as a technical expert, you will manage complex quality challenges, oversee NC/CAPA activities, support audits, and mentor team members on quality practices while contributing to enhanced product reliability and process optimization.

Key Responsibilities
 - Collaborate with cross-functional teams (Operations, QC, QA) to analyze, resolve, and escalate quality issues.
 - Lead investigations into non-conformances and CAPAs, including root cause analysis, risk assessments, and implementation of corrective/preventive actions.
 - Maintain and support GMP training compliance by managing the curriculum matrix, preparing updates, and assisting management with assessments and content reviews.
 - Serve as the primary contact for audits and inspections, coordinating department-wide support and ensuring readiness.
 - Develop, maintain, and report weekly/monthly quality metrics related to GMP training, document reviews, non-conformance, and CAPA tracking.
 - Manage record-keeping for the department, supporting data integrity, proper archiving, and documentation compliance.
 - Promote quality awareness by sharing key topics and preventing recurring issues within the department.
 - Work independently to meet deadlines while ensuring adherence to company policies and quality standards.

Requirements
 - Minimum 4 years of experience in the (bio)pharmaceutical industry or a relevant academic background.
 - At least 2 years of experience supporting quality functions such as NC/CAPA management, GMP training, and document/record control.
 - Strong communication skills in English, capable of engaging effectively with stakeholders at all levels.
 - Experience with risk management tools such as FMEA and HACCP, and root cause analysis methods like 5-Whys, Ishikawa, or Kepner-Tregoe.
 - Ability to present and defend QA practices and findings to senior leadership.
 - Strong analytical mindset with the ability to manage complexity, ask critical questions, use data for  - decision-making, and propose innovative solutions.
 - Proficient in MS Office and familiar with tools such as Tableau and electronic document management systems (eDMS).

Other Information
 If you are passionate about improving quality performance, driving compliance, and contributing to a high-impact engineering environment, this role offers an excellent opportunity to create meaningful value and grow your expertise.
 

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