Key Skills

Job Description

About the role As Quality Assurance Manager, you are ultimately responsible for developing, implementing and maintaining the quality management system at Loparex Apeldoorn, in accordance with ISO 9001 and GMP and, where applicable, other customer-specific quality standards. You are the system owner of all quality-related processes on site, you report to the Global Quality Director, and you are a member of the local management team. You directly manage a team of approximately 5 QA employees, indirectly manage 4 QC employees, and hold final responsibility for the release of manufactured product. You build capability within your team and ensure that Apeldoorn's quality program remains demonstrably healthy. Key responsibilities Leadership: Lead the Quality Assurance and Quality Control team and drive the execution and improvement of results. Eliminating quality losses: Develop and execute master plans to address quality losses and build capability; evaluate and improve the effectiveness of inspection and testing procedures. Non-conformities: Identify and isolate non-conforming products, determine root causes and recommend improvements. Release & inspection: Oversee the inspection and testing of incoming raw materials, semi-finished and finished products, with final responsibility for product release. Process ownership: Manage quality systems such as document control (QMS), internal and external audits, CAPAs, deviations, risk management and releases; act as process owner of the customer complaints system and of quality-related meetings. Coaching: Coach on root cause problem solving for chronic quality issues and develop Continuous Improvement and Lean skills across the organization. Health checks & training: Conduct regular quality health checks and/or witness audits. Identify gaps and implement appropriate measures; review and coordinate training plans. Compliance: Ensure work is carried out according to established procedures and to safety, health, environmental, quality and housekeeping standards. What do you bring? Bachelor's level of thinking and working (HBO/HBO+); a bachelor's degree in chemistry, chemical engineering or equivalent experience is a plus. At least 5 years of experience in a managerial role within a production-oriented organization. Knowledge of statistical techniques, including SPC, Lean Manufacturing and Six Sigma. Knowledge of and expertise in ISO standards and GMP guidelines. Strong persuasiveness and perseverance. Good communication skills to discuss quality issues with external and internal customers. Fluency in Dutch and English, both spoken and written, is required. A valid permit to work in the Netherlands. Experience in quality roles within the pharmaceutical, medical device or another highly regulated industry is a plus. Why join us? A salary between €5,500 and €8,500 gross per month, based on 36 hours per week. 27 vacation days. Plenty of room for initiative and growth. An international environment with a down-to-earth culture. The chance to join a dynamic, innovative team working together to build operational excellence at a global leader in its market.

Core Responsibilities

Lead the site’s Quality Assurance and Quality Control teams and own the quality management system, including audits, document control, CAPAs, deviations, risk management, customer complaints, and product release. Address quality losses and non-conformities through root cause analysis, inspections, training, health checks, and continuous improvement initiatives.

Requirements

Requires at least five years of managerial experience in a production-oriented organization, knowledge of statistical techniques, Lean Manufacturing, Six Sigma, ISO standards, and GMP guidelines, and fluency in written and spoken Dutch and English. Bachelor’s-level thinking and working is required; a degree in chemistry or chemical engineering, experience in a highly regulated industry, and a valid permit to work in the Netherlands are specified.

Benefits

• 27 Vacation Days
• Opportunities for Initiative and Growth
• International Work Environment