GCP Pharmaceutical QA Senior Manager

About Atrium :

What you do matters . As a people-centric organization, we foster an environment of collaboration, high performance, and innovation where your talents are valued, and your achievements are celebrated. Join us and become part of an inclusive team.

Client Overview :

Our client is a mid-sized biopharmaceutical company looking for a GCP Pharmaceutical QA Senior Manager !

Salary / Hourly Rate :

95 / hr - $100 / hr

Position Overview :

The GCP Pharmaceutical QA Senior Manager will be the Program Lead, providing CQA oversight of clinical studies. The successful candidate will lead inspection readiness and audit activities

Responsibilities of the GCP Pharmaceutical QA Senior Manager :

• Overseeing protocol, company SOPs, GCPs and Regulatory Guidance.
• Lead study audit plans.
• Lead execution of Phase II and III trials.
• Manage CAPA and site level inspections.

Required Experience / Skills for the GCP Pharmaceutical QA Senior Manager :

Strong GCP experience.

Clinical Trial Oversight and Operations.

Experience with quality events and outsourced audits.

Experience supporting Phase I, II and III.

Experience leading audits.

Education Requirements :

Bachelor's degree is required

Master's degree is preferred.

Benefits :

Medical.

Dental.

Vision.