Parexel FSP is looking for Asset Quality Lead, Directors! Candidates can be based anywhere in Brazil, Argentina or Mexico!
JOB OVERVIEW
The Asset Quality Lead (AQL) is responsible for driving GCP Quality by maintaining ‘quality’ line-of sight for assigned clinical trial programs/protocols. With this focus, the AQL role brings deep knowledge of GCP quality and risk management principles to asset and study teams. In partnership with the cross functional study team and functional lines in Clinical Development & Operations, the AQL will ensure program and study level quality oversight, drive quality risk management and inspection readiness activities and will be instrumental in ensuring that asset and study level information is appropriately incorporated within the GCP QMS. The AQL is the point person to the cross functional study team and other relevant stakeholders for quality risk management, quality issues management and general GCP guidance.
JOB RESPONSIBILITIES
Asset-Level Quality Oversight
Strategically, utilize quality measures/data to monitor asset/study quality and identify potential risks, quality trends, and support state of quality reporting
Study-Level Risk Management Plan Development and Oversight
Inspection Readiness, Preparation and Support
In conjunction with IMQA, coordinate business line GCP inspection support activities including but not limited to requests for dossiers, pre-inspection requests, during inspections and through the development of written responses to findings.
Business Development
Where appropriate, perform Quality Integration activities including but not limited to: representing quality functional lines at integration workshops or operational workshops, facilitating GCP Quality Integration Workstreams, and developing quality project plans for GCP business deal activities (e.g., integration operations)
Escalation, Communication, and Governance
QUALIFICATIONS / SKILLS
BASIC QUALIFICATIONS
Strong, advanced knowledge, experience and expertise in ICH GCP, clinical trial development, and operational GCP quality management disciplines such as, quality and compliance assessments, quality assurance, CAPA management, deviation management, root cause analysis, audit and regulatory inspection process, and/or inspection readiness.
PREFERRED QUALIFICATIONS
o Quality and compliance management, QC
o Root Cause Analysis
o Metrics development and utilization
o Audit and Inspection conduct
o CAPA development and response process
o Inspection Readiness
o Project/initiative coordination and management skills
