A well-established, global, pharmaceutical client is seeking to add to their dynamic quality team. 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 an Associate Director/Director of Quality. In this role, you will be providing leadership to a team involved with building and/or maintaining robust GMP quality systems. You will take the lead in providing oversight for quality systems (including metrics/tracking) as well as oversight of other GMP QA activities involving validations in support of manufacturing (equipment, etc.).
The role requires minimal travel.
BS level with at least 12-15+ years in a Quality role focused on GMP quality systems (implementation, monitoring, improvement etc.).
Previous direct experience with quality approvals of manufacturing equipment validation, management of CAPAs, etc.
Previous direct supervisory experience is required.
Thorough knowledge of FDA, EU and other global GMP guidance and regulations.
Must have a strong background working with small molecules, background in solid oral dosage forms or parenterals is preferred.
Proven ability to design and implement corporate quality systems changes.
Ability to work in a fast-paced environment.
Excellent written and oral communication skills.
Excellent leadership and mentoring skills.
Experience with Trackwise a plus.
Please note: I will only be able to reply to those candidates who meet my client's specific criteria.
I look forward to hearing from you!
Joanne Gehas, Ph.D.
FPC of Raleigh
FPCNational - 16 months ago