- They have a lot of audits scheduled this year. The Candidate will be asked as they define schedules for the sites, to be ready for travel anywhere from 10-20 days from Audit dates for the next 4-5 months. Needs to have an open schedule and able to take on the timing for these months. Should be decent amount of audits over 4-5 months.Supports Principal GCP Lead with GCP audits and Inspection Readiness activities.
Responsible for the planning and delivery of global GCP audits for both Pharma and Med tech, including mock agency inspections and Quality Management System development Essential Functions
• Responsible for developing, performing, and managing, in cooperation with Principal GCP Lead, all Quality Assurance related activities such as performance of contracted GCP audits to include Site and vendor audits. In collaboration with the Principal GCP lead performs gap analysis by assessing client studies, procedures, and programs against global standards, identify inherent and applied risk and subsequently supports QMS build for various stakeholders to include sponsor organizations specifically surrounding GCP and GxP activities.
• Leads mock regulatory inspections and remediation actions to assure regulatory compliance.
• In collaboration with the Principal GCP Lead develop standard operating procedures and quality audit tools to support research activities
• Available to travel both US domestic and International
• Ability to control budgets and ensure adherence to project requirements
• To be able to work with Principal GCP Lead in identifying new solutions
• Identify improvements to existing solutions and always work towards operational excellence
• Bachelor’s Degree required
• Minimum of ten years of GCP (Good Clinical Practice) experience
• Minimum of 2 years auditing experience
• Works willingly and effectively with others in and across the organization to accomplish team goals
• Knowledge and understanding of the fundamental processes of business, their interaction, and the impact of external/internal influences on decision making Excellent interpersonal and networking skills.
• Values people’s opinions and encourages knowledge sharing. High level of energy, drive and enthusiasm
• Able to manage complex relationships and juggle priorities
• Excellent client relationship and influencing skills.
Preferred but not essential Qualifications
• Good Laboratory Practice (GLP) experience
• Knowledge in applying GCP to RWE/non-interventional studies
US and Europe: GCP Senior Auditing Consultant (232662)