Compliance Specialist

A large pharmaceutical company based in New York is in immediate need of a Compliance Specialist consultant to join the External Manufacturing Compliance team for a 12-month project (potential for extension past 12 months). The project will need to be completed while working every day on-site.

The company is growing is very quickly and this consultant is needed to support an increase in workload. The client outsources multiple functions to external partners for filling, packaging, etc. and also for drug substance, the Compliance Specialist needs to ensure anything coming from CMOs meets requirements or if anything needs to go through the Change Control process. The Consultant will need to be an expert working within Quality Systems as an owner of Change Control, Deviations, and CAPA records

Project Scope

• Own and manage External Manufacturing items through Quality System including Change Control proposals, CAPAs, and SCARs for clinical and commercial external mfg.
• Collaborate across the department and partner with External Manufacturing Operations relationship leads
• Facilitate meetings to manage priorities and ensure current status updates
• Contribute to improvements in External Manufacturing department SOPs. May lead reviews, audits for compliance, and revisions of SOPs

Top Requirements

Experience interacting with CMOs

or other external groups like corporate partners, preferably in an External Manufacturing or QA role