Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.

Quality Control Submission Manager Job

Eingestellt von Yoh

Gesuchte Skills: Support, Client

Projektbeschreibung

QUALITY CONTROL SUBMISSION MANAGER needed for a CONTRACT opportunity with Yoh's client located in East Hanover, NJ.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- GCP Knowledge
- Regulatory Submission Document Knowledge

WHAT YOU'LL BE DOING:

- Calculating and reporting of monthly key quality metrics in graphical form (ie 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

WHAT YOU NEED TO BRING TO THE TABLE:

- 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)

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Kara Lloyd

Yoh, a DayJ2W: CLINICAL

MONJOBJ2WNECLIN

Ref:

SFSF: LS

Projektdetails

  • Einsatzort:

    East Hanover, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Yoh