6+ months- possible extension/ chance for conversion
Our client is looking for a Director of Clinical QA that will be managing/directing the ongoing Clinical QA activities to support GCP and Clinical Trial Obligations. You will support clinical development and you will be empowered to develop clinical quality programs and systems as you represent and manage Clinical QA.
Collaborate with Clinical Development and all related functional areas to ensure that clinical trial activities are conducted in compliance with Good Clinical Practice (GCP) regulations, the International Conference on Harmonization (ICH) and Policies and Procedures.
Interpret and provide key metrics to Clinical Development Team, Quality Team and cross-functional development team members
Support GCP SOP development and serve as quality operations reviewer. Serve as a strategic GCP quality resource providing GCP technical guidance recommendations to development teams
Execute risk-based methodologies for the planning and execution of clinical protocols
Manage clinical quality issues including audit reports, quality issues/incidents, and CAPA development, working closely with QA 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.
Lead systems monitoring and process improvement initiatives that enhance regulatory compliance and CQA operating efficiency.
Assist with inspection readiness and inspection preparation activities, including SME training/preparation and back room activities, and back room during GCP inspections. Analyze the risks, propose the strategy for readiness and manage the implementation of readiness program.
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.
Support continuous improvement activities
Present key issues related to clinical quality to Quality Management
Be a self-starting problem solver who drives results through high compliance and a positive work style.
Bachelor of Sciences Science, Nursing, or related scientific field, or higher, is required.
10+ years of experience in the pharmaceutical or biotechnology industry with 5 years of GCP-related Quality Assurance experience.
In Depth knowledge of the applicable global GCP regulations, Good Clinical Practices, ICH Guidelines
Remote in MA: Director of Clinical QA GCP (233848)