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QUALITY MANAGER
As Quality Manager, you will play a key role in maintaining, overseeing, and continuously improving the Quality Management System (QMS) within a GMP-regulated and non-GMP laboratory environment.
In this hands-on position, you will ensure compliance with applicable regulations, industry standards, and internal quality requirements while actively supporting daily quality activities.
As Lighthouse operates in both GMP and non-GMP environments, a strong understanding of risk management and a broad perspective on quality and compliance are essential.
You will be responsible for assessing risks, providing compliance guidance across the organization, and ensuring that quality principles are applied appropriately to diverse activities.
Your responsibilities include managing audits, change controls, nonconformances, CAPAs, and training processes, while driving continuous improvement and fostering a quality-focused culture throughout the business.
Key responsibilities:
¬ Ensure the maintenance, continuous improvement, and compliance of the Quality Management System (QMS).
¬ Manage GMP training activities, including the development, delivery, and coordination of initial and ongoing GMP training programs for QA personnel and company employees to ensure compliance with operational requirements.
¬ Manage the quality documentation system, ensuring regulatory compliance and availability of current and approved documentation. Responsibilities include:
• Coordinating the creation, review, revision, and approval of quality system documents;
• Ensuring document validity and lifecycle management;
• Reviewing and approving Quality Policies and Standard Operating Procedures (SOPs).
¬ Lead Quality Risk Management activities by facilitating risk assessments and ensuring appropriate quality involvement in business processes based on risk level and regulatory
expectations.
¬ Manage supplier qualification and oversight activities, including:
• Qualification, evaluation, and monitoring of suppliers;• Maintenance of the Approved Supplier List.
¬ Manage audit- and inspection activities, including:
• Planning and execution of internal audit according to the annual audit plan;
• Acting as Quality representative during customer audits and regulatory inspections;
• Supporting both front-office and back-office audit activities.
¬ Manage the QMS processes by monitoring effectiveness, evaluating proposed quality records, ensuring appropriate impact assessments, and approval in accordance with QMS requirements.
¬ Act as primary Quality contact for customers regarding quality system-related requests and requirements:
• Manage, review, and finalize Quality Agreements with customers;
• Ensure agreements remain current and compliant;
• Ensuring timely completion and review of customer quality questionnaires.
¬ Provide leadership, mentoring, and coaching to QA team members and contribute as a member of the management team.
¬ Maintain and oversee computerized systems compliance, including:
• Audit trail reviews;
• Periodic system reviews;
• Computerized System Validation (CSV) activities.
¬ Oversee equipment qualification activities, including review and approval of IQ/OQ/PQ protocols and qualification reports.
Qualifications / Requirements:
¬ BSc degree in Life Sciences/Chemistry/related fields;
¬ Experience with Microsoft Office and Quality Management systems;
¬ 2 – 5 years of relevant GMP experience preferably in laboratory environment;
¬ Strong ability to adapt in dynamic environments;
¬ Strong self-reliance skills with the ability to work independently;
¬ Ability to work effectively with multicultural colleagues and -customers;
¬ Flexible personality: adapt to unexpected and urgent requests;
¬ Very well organized and able to set priorities with acute attention to detail;
¬ Strong written and verbal communication and presentation skills in English, proficiency in Dutch is a plus;
¬ You reside in or near Diemen and have a valid ‘BSN’
Working hours
The position is for 32 – 40 hours per week during office hours. Hybrid work is possible in consultation.