A leading biotech, more than 25 years in the industry, is looking for a Director of Development Operations Compliance to join their team. Striving to find new medications for cancers that are difficult to treat, this company continues their mission to accelerate new discoveries. With new products on the horizon, this would be an exciting time to join!
Implement tactics and strategies to maintain and promote GCP Compliance and process improvements for clinical trials. This will be performed by Clinical Operations, Clinical Data Management, Biostatistics, & Clinical programming.
- Co-Lead Development Operations inspections prep activities.
- Create and implement processes to improve data integrity and quality for clinical trials and ensure continuous inspection readiness according to GCP guidelines.
- Act as a resource for Development Operations personnel for issues relating to GCP, non-compliance surveillance, process optimization, SOP/CAPA authoring.
- Review and write SOPs and provide input during the review of cross-functional SOP review.
- Co-lead compliance activities including SOP and training compliance; support teams with risk management/mitigation in accordance with the requirements of ICHE6(R2).
- Advises on content of audit report responses and CAPA and partner with Root Cause Analysis.
- Interpret clinical trial regulations and guidelines to provide routine and urgent guidance to stakeholder.
- Partner with the Quality Assurance group on remediation of quality issues related to conduct of clinical studies. Act as a liaison with the Quality group to ensure coordination and communication of quality driven initiatives, to ensure alignment on compliance decisions and recommended actions implementation.
- Develop and facilitate training sessions on regulatory requirements guidance, best practices, trends, and GCP topics to conducts continuous improvement in study execution and on-going adherence to regulations and standards
- BS/BA degree in related discipline and eleven years of related experience; or,
- MS/MA degree in related discipline and nine years of related experience; or,
- PhD in related discipline and six years of related experience, or;
- Equivalent combination of education and experience.
- 15 years related experience and/or combination of experience.
- 12 years of biotechnology/pharmaceutical/CRO in quality management of training, clinical trials, project management, and clinical operations.
- Experienced in leading inspection readiness activities.
- Advanced knowledge of ICH-GCP guidelines and applicable drug development regulations.
- Experienced in leading the development of SOPs and other process related documentation.
- Experienced in supporting clinical trial GCP compliance/quality management activities.
- Strong understanding of drug development and clinical trial execution, including other required functional areas involved in clinical trials.
- Supported GCP Inspection readiness activities and participated in regulatory authority inspections.
- Expertise in implementation of the FDA BIMO manual for inspections of sponsors and CROs.