Contract Position!We are partnering with a leading cell therapy organization seeking a Senior Specialist I, Quality Systems to support and enhance site-wide Quality Systems within a highly regulated GMP environment. This is an excellent opportunity to join a team focused on delivering innovative cancer therapies while driving compliance, quality, and continuous improvement initiatives.Key ResponsibilitiesManage and maintain Quality Systems including Change Control, Deviations, CAPA, and Material Review Board (MRB) processes.Deliver Quality Systems training and provide ongoing compliance support across the site.Act as chair or deputy chair for Quality Review Boards and cross-functional committees.Support regulatory inspections, audits, and quality compliance activities.Review and approve deviations, CAPAs, quality records, and procedural changes.Monitor, analyse, and report Quality System metrics to support continuous improvement.Maintain GMP documentation and Quality Management System compliance.Collaborate with internal stakeholders across Quality, Manufacturing, and Technical Operations teams.Support cross-site initiatives and process improvement projects.RequirementsBachelor's Degree in Chemistry, Microbiology, Engineering, or a related scientific discipline.Minimum 5 years of Quality Assurance experience within a GMP-regulated pharmaceutical, biotech, or manufacturing environment.Strong experience with:Change ControlDeviations & CAPA ManagementMaterial Review Boards (MRB)Internal AuditsICH Q10 Quality SystemsEU GMP RegulationsStrong understanding of aseptic manufacturing processes.Experience using Quality Management Systems and Microsoft tools including Excel, Power BI, Power Automate, and Smartsheet.Preferred ExperienceATMP, Cell & Gene Therapy, or Biologics experience.ASQ, Lean Six Sigma Green Belt, or Black Belt certification.Personal AttributesStrong communication and stakeholder management skills.Flexible, pragmatic, and collaborative approach.Ability to work independently within a fast-paced GMP environment.Passion for quality, compliance, and continuous improvement.If you're an experienced Quality professional looking for your next contract opportunity within an innovative and patient-focused organization, apply today or contact me directly for further information.

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