Quality Assurance Manager - Research Services

Primary Responsibilities

• Serve as the Quality Management System (QMS) lead and subject matter expert, partnering with VES and Epidemiology (EPI) teams to embed quality, compliance, and governance practices into daily operations and project delivery
• Establish, maintain, and continuously improve quality management practices for VES and EPI services, including SOPs, controls, governance processes, and quality standards
• Ensure alignment of quality processes and documentation with internal QMS requirements, client expectations, industry best practices, and applicable regulatory requirements
• Develop and coordinate responses to QA/QMS-related client Requests for Information (RFIs), vendor qualification questionnaires, due diligence requests, and quality assessments
• Review and advise on quality-related contractual language to ensure compliance with organizational policies and client requirements
• Maintain and administer the QMS, including SOP development and management, training records, policy attestations, quality documentation, and controlled records
• Organize and monitor key quality activities and timelines, including SOP reviews, audit schedules, training compliance, CAPA tracking, and governance requirements
• Act as the primary point of contact for client audits, vendor audits, and regulatory inspections, including audit planning, scope and agenda coordination, stakeholder preparation, evidence collection, audit facilitation, and follow-up activities
• Lead audit and inspection readiness activities for VES and EPI, ensuring maintenance of inspection-ready artifacts, supporting documentation, quality controls, and evidence repositories
• Manage corrective and preventive actions (CAPAs), including root cause analysis, remediation planning, tracking, and verification of effectiveness
• Partner with internal and external audit teams to assess compliance with quality processes, identify risks, and implement corrective actions
• Conduct internal and vendor audits to evaluate compliance with established procedures, controls, and quality standards
• Develop and maintain quality metrics, reporting, and analysis to monitor performance, identify trends, assess compliance, and drive informed decision-making
• Design, facilitate, and evaluate quality improvement initiatives that strengthen operational effectiveness and support a culture of continuous improvement
• Promote quality awareness, audit readiness, compliance, and operational excellence across VES and EPI

Required Qualifications

• 3+ years of experience in quality management, compliance, or a related field
• 2 years of experience working in regulated environments (e.g., healthcare, life sciences, data governance)
• Intermediate to Advanced experience with technical writing (i.e. how to create process flows, SOPs using Visio, interview SME and create documented practices. Know how to write non-conformance and corrective actions)
• Intermediate experience with MS Office - Visio
• Demonstrated ability to communicate effectively on a regular basis with Compliance, Legal, Engineering and Data team stakeholders
• Ability to travel up to 10% to Boston, MA office

Preferred Qualifications

• Experience supporting quality reviews, audits, or regulatory readiness activities
• Experience of working within life science sector
• Experience working within a Quality Management System (QMS)