Clinical Quality Assurance Lead

ProPharma is seeking a Clinical Quality Assurance Lead to join their team. The successful candidate will be responsible for hosting and supporting client audits and regulatory authority inspections, as well as providing subject matter expertise on quality topics.

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 to CRS/FSP staff
• Participate in CRS/FSP Client operational meetings requiring CQA representation
• 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
• Identify and escalate any issues that could potentially impact services
• Support the delivery of the internal quality program

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance