Clinical Quality Assurance Lead - 18 month Fixed Term Contract

Clinical Quality Assurance Lead to join the global QA Team on an initial 18-month Fixed Term Contract. The role provides guidance for quality activities, drives positive change, and process improvement. The Clinical Quality Assurance Lead will perform, develop, manage, and execute quality management processes to ensure quality standards are maintained and compliant with regulatory requirements.

Requirements

• Host and/or Support CRS/FSP client audit and/or regulatory authority inspection activities
• Develop responses to CAPAs arising from client/inspections
• Collaborate with multiple lines of business to prepare for/conduct audits/inspections
• Coordinate Client Questionnaire Audits
• Perform review and approval of Deviations, Quality Events, CAPAs, and Effectiveness Checks in the eQMS
• Support CRS/FSP project leadership in setup and subscription of Client and/or project-specific Deviation, Quality Event, and CAPA eQMS reports
• Conduct periodic review of Deviation, Quality Event, and CAPA eQMS reports
• Escalate emerging trends to Management for improvement opportunities
• Perform GxP change management activities
• Provide ongoing GxP Subject Matter Expertise (SME) to CRS/FSP staff
• Participate in CRS/FSP Client operational meetings
• Contribute to the creation of controlled documents
• Perform quality review and approval of CRS/FSP and/or Quality Assurance controlled documents
• Collaborate in the review and approval of CRS/FSP computerized systems related validation documentation in the eQMS
• Identify any issues which could potentially impact services and escalates any areas of concern within the business to Management

Benefits

• Health insurance
• Retirement plan
• Paid time off
• 401k matching