Clinical Quality Assurance Lead - 18 month Fixed Term Contract

Clinical Quality Assurance Lead position at ProPharma, responsible for guiding quality activities and driving process improvement in a regulated environment.

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 and serve as SME for applicable quality topics
• 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 for Client provision
• Conduct periodic review of Deviation, Quality Event, and CAPA eQMS reports to facilitate identification of emerging trends
• Escalate emerging trends to Management for improvement opportunities
• Perform GxP change management activities including risk and impact analysis review, change plan review and approval, action implementation to completion, and eQMS record management
• Provide ongoing GxP Subject Matter Expertise (SME) to CRS/FSP staff
• Participate in CRS/FSP Client operational meetings requiring CQA representation
• Contribute to the creation of controlled documents such as SOPs and Work Instructions
• 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, with potential corrective actions
• Support the delivery of the internal quality program including quality assurance and quality control
• Maintain awareness of and ensure adherence to applicable SOPs/ controlled documents, applicable GxP regulations, and client agreements

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Tuition Reimbursement