Senior Associate

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