Specialist/Sr. Specialist - Global Audits, Inspections, and QMS (AIQ)

The QMS and Reporting Support Contractor position within AIQ will serve as an enabler of multiple QMS initiatives, as well as support reporting and data analysis deliverables. This individual will report into the QMS and Reporting pillar of AIQ and partner with various GxP stakeholders who provide data input and deviation record ownership. Key Responsibilities Deviation Training Program & Support Model ExecutionSupport implementation of a deviation investigator training pilot program, incorporating adult learning principles and hands-on applicationDevelop training materials (case studies, templates, guidance tools) to improve investigation quality and consistencyPartner with QA and deviation owners to establish a sustainable support model (office hours, coaching, knowledge resources)Analyze training program effectiveness metrics (e.g., quality of investigations, cycle times, rework trends) to inform program improvements and scalability Quality Metrics, Scorecard & KPI EnhancementSupport execution and delivery of Quality scorecards, dashboards, and KPI frameworksPerform data aggregation, trending, and root-cause-oriented analysis across deviations, CAPAs, and change controlsSupport routine and ad hoc reporting requests for Quality Management Review and Quality Systems forums, ensuring data accuracy and consistencyProvide project management support across QMS initiatives (timelines, deliverables, stakeholder follow-ups) QMS Process Support & Technology EnablementAssist with process mapping, gap assessments, and continuous improvement initiatives across QMS processesSupport data governance and data clean-up initiatives within the QMSLeverage Alnylam approved AI tools and technologies to advance analytics and enable Quality record completeness and accuracy Key Competencies Strong process thinking and analytical skillsStrong experience in ExcelExcellence in project management and organizationStrong communication and facilitation skillsAbility to influence without direct authority and self-starterStrong technical writing skillsDemonstrated ability to leverage AI-enabled tools while ensuring GxP compliance and data integrity principles Requirements Bachelor's degree in Life Sciences, Engineering, or related discipline3-5 years of experience in GxP Quality Systems, QA operations, or QMS program supportStrong understanding of GMP, GLP, GCP regulations and ICH guidelinesQuality Management System processesQuality metrics, dashboards, and KPI developmentData analysis and trending (Excel, Power BI, or equivalent tools)Electronic quality management systems (Veeva strongly preferred) Preferred Qualifications Experience with electronic Learning Management Systems and Document Management SystemsExperience with change management and organizational development Benefits Contract position with possible extension