· Supporting all phases of Client's clinical development programs to plan, control and improve the quality in accordance with international standards for Good Clinical Practice
· Partnering with development team(s) to drive quality within the team(s)
· Develop and implement quality management plan for each assigned program
· Interpret and provide key metrics to Global Development Team Leader and cross-functional development team members
· Support GCP SOP development and serve as quality operations reviewer.
· Execute risk-based methodologies for the planning and execution of clinical protocols , assuring an ongoing cycle for Plan – Do – Check – Act
· Manage quality issues including audit reports, quality issues/incidents, and CAPA development, working closely with RDQ audit team and clinical development. Ensure timely implementation and closure of CAPAs.
· Facilitate the assessment and investigation of quality issues, by driving root cause analysis and remediation. Provide expertise and recommendations. Ensure timely review and closure of quality issues.
· Assure appropriate escalations and notification to line management
· Lead inspection readiness and inspection preparation activities, including SME training/preparation and back room activities, and manage back room during GCP inspections. Analyze the risks, propose the strategy for readiness and manage the implementation of readiness program. Provide lessons learned after each GCP inspection.
· Use knowledge of GCP, clinical development, and industry best practices in order to provide guidance, training and input to business partners on compliance issues. Able to adapt precedent and develop creative and effective solutions to solve problems.
· Manage temperature excursions occurring during shipment and site/patient home storage. Collaborate with partners in Global Clinical Supply and GMP QA to address excursions.
· Mentor other Clinical Quality Operations Quality Leads; may have supervisory responsibilities within Clinical Quality Operations.
· Minimum of 8 years of experience pharmaceutical or biotechnology drug development experience
· Experience managing clinical quality activities and knowledge of clinical operations
· Comprehensive knowledge of all pertinent regulations
· Bachelor’s degree required. Masters preferred
· Excellent communication, negotiation, and customer service skills.
· Demonstrated attention to detail, accuracy, excellent review and analytical skills in a fast-paced environment.
· Results oriented; able to determine approaches to assignments
· Strong interpersonal skills while building/keeping/monitoring quality and compliance
· Problem-solving skills with ability to analyze situations and/or data while considering future impact and intangible variables
· Multitasks and ability to manage multiple global processes