Supplier Quality Manager
Northern, NJ
An Innovative pharmaceutical company is currently seeking a Supplier Quality Manager to join its rapidly expanding team. This company was founded back in 2009, and already has had a tremendous amount of success in the generics space! This newly created position will give you the ability to join a company with tremendous amounts of growth potential. If you are looking to expand your career in QA then don't hesitate to apply!
The Supplier Quality Manager will have the following responsibilities:
- Documentation Review & Approval:
- Review and approve documentation such as Method Validations, Manufacturing Records, SOPs, Investigations, Change Controls, Validation Reports, Equipment Qualifications and similar documents as directed by Quality Management.
- Inspections and Audits:
- Prepare / Support preparation activities for regulatory inspections
- Evaluate regulatory agency findings from inspections conducted at CMOs/CPOs/analytical Laboratories, etc.
- Support the design and implementation of system / process improvements where opportunities are identified (Commercial & Development), including associated CAPA's.
- Support technical transfer / validation activities with external business partners / CMOs.
- Manage the Commercial Finished Product / Bulk Drug Product Release System:
- Communicate with external business partners / CMOs regarding quality related issues and Quality Agreements.
- Track metrics for external business partners / CMOs on change controls, deviations, complaints, audits, product releases and rejections and other Third-Party Quality Key Performance Indicators.
- Mentor and develop other QA manager's on team on R&D QA related topics.
The ideal candidate will have:
- Experience with vendor management
- 7 + years QA experience
- R&D QA experience
- Commercial QA experience
- Bachelors degree in a related discipline
