Senior QA Specialist

ppbLocation: /b Sassenheim, Netherlands (Hybrid - 3 days onsite) /p pbHours: /b Full-time (40 hours per week) /p pbSector: /b Pharmaceutical / Biotech / GMP Compliance /p h3About the Role /h3 pWe are looking for an bexperienced Senior QA Specialist (GMP) /b to support the new viral‑vector manufacturing facility in Sassenheim. As the site moves toward commercial readiness, the team needs someone who can step in quickly, operate independently, and take clear ownership of their responsibilities in a dynamic and fast‑paced environment. /p pYou will play a key role within the Quality organization, working closely with Operations and the Centre of Expertise (CoE) to ensure processes, documentation and systems meet the highest compliance standards and are fully audit‑ready. /p h3Key Responsibilities /h3 ul liReview, update, and maintain bGMP documentation /b to ensure regulatory and internal compliance /li liLead bdeviations /b, broot‑cause analyses (RCA) /b, bCAPA /b activities, and bchange controls /b /li liSupport and/or facilitate bQuality Risk Assessments /b /li liContribute to baudit readiness /b, including acting as SME where required /li liCollaborate with Operations and the CoE to translate technical processes into compliant, shop‑floor‑ready workflows /li liProactively identify improvement opportunities and independently initiate and follow up on actions /li /ul h3Who We're Looking For /h3 pWe are seeking a bsenior professional /b who is not only technically strong but also able to present themselves confidently and navigate a complex, high‑tempo environment. /p h3Must‑haves /h3 ul lib8+ years of GMP experience /b in biotech or pharmaceutical manufacturing /li liDemonstrated hands‑on experience with bdeviations, investigations, RCA, CAPA change controls /b /li liStrong understanding of bcGMP /b requirements (Annex 1 experience is a significant advantage) /li liExcellent communication skills and the ability to present yourself with confidence and clarity /li liA proactive, self‑driven approach with the ability to take ownership in a busy environment /li liStrong stakeholder management skills and the ability to prioritize effectively /li /ul h3Preferred /h3 ul liExperience supporting audits or inspections in manufacturing environments. /li liFamiliarity with viral vector, biologics, or aseptic production environments. /li liAbility to manage multiple priorities and devise effective solutions in a fast‑paced setting. /li /ul /p #J-18808-Ljbffr