A well-established pharmaceutical client is seeking to add to their dynamic quality department. Now is an exciting time to join this organization, which has a robust pipeline of products in development in a variety of therapeutic areas as well as currently approved drugs on the market.
Due their continued growth, my client has created a new opportunity for a Senior Manager, Quality. In this role, you will be providing quality support for ensuring all technical transfer activities between commercial manufacturing sites or from pilot facilities to commercial manufacturing facility are within compliance. This would include quality oversight of validation and commercial change management activities (validation assessment, approvals for protocols, SOPs, specifications, etc.). You would also serve as a quality lead on any related manufacturing investigations/CAPAs related to technical transfer activities.
The role requires travel (estimated to be up to 25%, within the US, but also some international travel).
BS level with at least 10+ years in a Quality compliance role working within a pharmaceutical technical transfer manufacturing environment.
Experience with batch failure investigations and validation is required.
Experience with auditing of third party manufacturing vendors is preferred.
Experience with solid oral dosage forms and/or parenterals is preferred.
I look forward to hearing from you! Only those candidate who meet my client's specific requirements will be contacted.
Joanne Gehas, Ph.D.
FPC of Raleigh
FPCNational - 19 months ago