Senior Associate

Pennsylvania  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Description

Role Description:
  • Drives excellence in Quality by maximizing our Partner collaboration to ensure Patients confidence in our Products.
  • Responsible for the Quality management of approximately 300 contract manufacturers, packagers, and supply partners globally.
  • Will be responsible for regulatory change management activities, management of routine complaints and execution of lot disposition activities for the Drug Products and Drug Substances (APIs) manufactured by managed Contractors.
Responsibilities:
  • Initiate, review and approve regulatory changes initiated by or impacting managed contractors.
  • Provide support for the closure of the deficiency letters and CMC Commitments, Regulatory requests for Renewals, New Product registrations and Post approval variations.
  • Serve as the main point of contact for the various regulatory activities involving the managed contractors.
  • As the Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) or similar meeting for managed contractors and if needed, participate in Site Quality visits at the contractors.
  • Manage routine Customer Quality complaints for commercial Drug Products and work in collaboration with the Contractor Quality Lead for ensuring that the investigation reports are appropriate and acceptable.
  • Ensure timely closure of complaints and alerting the appropriate colleagues for the confirmed complaints.
SKILLS:

Qualifications:
  • BA/BS in Science, Engineering, Pharmaceutical Sciences or related technical discipline
  • Minimum 5 years of experience in GXP setting (or 3 years with Masters degree)
  • Advanced in computer skills such as MS Office applications and good knowledge of enterprise systems such as Trackwise.
  • Good command of English language
  • Good verbal and written communication skills and able to work in diverse multi-level, cross-divisional and multi-cultural working environment
  • Show strong negotiation skills and customer focus
  • Demonstrate ability to prioritize work, manage multiple projects act and work independently
  • Take initiative and proactive
Start date
n.a
From
Synectics
Published at
23.06.2015
Project ID:
929179
Contract type
Freelance
To apply to this project you must log in.
Register