Senior Manager, Clinical Quality & GCP Systems

COUR Pharma; Evanston (IL); On-site; USD 100,000 - 135,000; Full time

Job summary

A progressive pharmaceutical company is seeking a Senior Manager of Clinical Quality Assurance and Quality Systems to maintain GCP compliance of all Clinical Operations. The role includes overseeing data flows, audit preparation, and managing Quality Management Systems improvements. Successful candidates will have substantial Pharma/Biotech experience, preferably with GCP and a strong track record in oversight of vendor relationships and system validations. This is a pivotal position reporting to the Vice President of Quality.

Qualifications

• 8+ years of Pharma/Biotech industry experience with 5+ in direct Clinical Trial support roles.
• GCP certification and defined Quality role track record preferred.
• Strong background in system-based validation.
• Experience in managing relationships and performance with GXP vendors/suppliers.

Responsibilities

• Ensure GCP compliance across all Clinical Operations activities.
• Own and improve SOPs related to a Risk-Based GCP Quality Program.
• Maintain inspection readiness for all documentation and systems.
• Facilitate Safety Review Board discussions as Quality point of contact.
• Monitor and trend KPIs related to clinical quality.

Skills

GCP compliance

Quality Management Systems (QMS)

Pharmacovigilance

KPI monitoring

Project Management

Education

Bachelor’s degree in business, medical, or scientific field

Advanced degree

Tools

eQMS

Job description

A progressive pharmaceutical company is seeking a Senior Manager of Clinical Quality Assurance and Quality Systems to maintain GCP compliance of all Clinical Operations. The role includes overseeing data flows, audit preparation, and managing Quality Management Systems improvements. Successful candidates will have substantial Pharma/Biotech experience, preferably with GCP and a strong track record in oversight of vendor relationships and system validations. This is a pivotal position reporting to the Vice President of Quality.