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

1. Deviation Training Program & Support Model Execution

• Support implementation of a deviation investigator training pilot program, incorporating adult learning principles and hands-on application.
• Develop training materials (case studies, templates, guidance tools) to improve investigation quality and consistency.
• Partner 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.

2. Quality Metrics, Scorecard & KPI Enhancement

• Support execution and delivery of Quality scorecards, dashboards, and KPI frameworks.
• Perform data aggregation, trending, and root-cause-oriented analysis across deviations, CAPAs, and change controls.
• Support routine and ad hoc reporting requests for Quality Management Review and Quality Systems forums, ensuring data accuracy and consistency.
• Provide project management support across QMS initiatives (timelines, deliverables, stakeholder follow-ups).

3. QMS Process Support & Technology Enablement

• Assist with process mapping, gap assessments, and continuous improvement initiatives across QMS processes.
• Support data governance and data clean-up initiatives within the QMS.
• Leverage Alnylam approved AI tools and technologies to advance analytics and enable Quality record completeness and accuracy.

Key Competencies

• Strong process thinking and analytical skills
• Strong experience in Excel
• Excellence in project management and organization
• Strong communication and facilitation skills
• Ability to influence without direct authority and self-starter
• Strong technical writing skills
• Demonstrated ability to leverage AI-enabled tools while ensuring GxP compliance and data integrity principles

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or related discipline.
• 3-5 years of experience in GxP Quality Systems, QA operations, or QMS program support.
• Strong understanding of GMP, GLP, GCP regulations and ICH guidelines
• Quality Management System processes
• Quality metrics, dashboards, and KPI development
• Data 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 Systems
• Experience with change management and organizational development

Benefits

• Contract position with possible extension