QC Submission Manager at Hanover

Job Description

Job Number: 413937

QC Submission Manager

QC SUBMISSION MANAGER
East Hanover, NJ

Calculating and reporting of monthly key quality metrics in graphical form (i.e. audit results and corrective and preventive actions status and associated reports) Involved in the reconciliation of IND submissions and IND amendments according to an established process Follow-up on outstanding corrective and preventive actions, manage to closure Coordination and assessment of SOP deviations and their reporting Support escalation process of potential issues Support for Oncology QA managers with meeting preparation, follow-up etc.

Support in GCP consultation with business partners Support for the preparation of training materials (webinars, slides) and participation in quality training sessions for the business partners

Skills

Experience in working in Quality in the GCP/clinical development area Project management skills and ability to manage others Robust understanding of a submission document especially the Clinical Modules (1, 2 and 5); SCE - Summary of Clinical Efficacy, SCS - Summary of Clinical Safety and the Clinical overview Robust understanding of GCP requirements and compliance with regulatory requirements Robust understanding of key Quality Systems principles (Compliance to SOPs, deviations, corrective and preventive actions, Key Quality Indicators) Able to work independently or with little direct oversight Attention to detail, reliable and flexible Good communicator Computer skills (Word, Powerpoint, Excel)

BA Degree

Job Requirements

 
Country: USA, State: New Jersey, City: Hanover, Company: Advanced Clinical.