We are seeking an experienced GMP Specialist to join the Quality department for a 6-month full-time contractor role, based in the Leiden area (minimum 3 days/week onsite). This position focuses on deviation and change control, providing oversight, support, and compliance enforcement across cross-functional teams including QA, QC, Manufacturing, Planning, and Supply Chain.You'll act as the operational interface between QA and the business, handling major quality events, leading process improvements, and supporting teams with GMP best practices. This is a hands-on, high-impact role ideal for someone with a strong QA background and a deep understanding of GMP in daily operations.Essential Requirements:7+ years of experience in GMP-regulated operations, ideally in QA or cross-functional roles within pharma or biotechStrong knowledge of deviation management, CAPAs, and change control processesOperational understanding of raw material handling, particularly materials/kits from third-party manufacturers (e.g., Lonza)Experience acting as a liaison between departments (QA, QC, Planning, Manufacturing, MSAT)Confidence to challenge or push back on management/QA where appropriateExperience writing and owning SOPs, work instructions, and GMP documentationExcellent problem-solving, communication, and mediation skillsBachelor's degree in pharmacy, chemistry, engineering, or a related fieldDesirable Requirements:Background in Supply Chain roles alongside QA experienceFamiliarity with Good Distribution Practices (GDP)Prior use of SAP and/or Quality Management Systems (QMS)Experience managing cross-functional deviation training or effectiveness checksUnderstanding of raw material flow to Decentralized Manufacturing Units (DMUs)Additional Insights:Start Date: ASAPDuration: 6-month contractEmployment Type: Full-time ConsultantLocation: Onsite in Leiden, Netherlands (minimum 3 days/week presence required)
