We are working with a Boston area clinical-stage pharmaceutical client looking to hire a full time Senior Manager, Clinical Quality Assurance, GCP. This person will support cross functional teams and external vendors and provide GCP compliance and issue resolution. The role will be directly involved in the development and continuous improvement of GCP quality and overall QMS.

Responsibilities:

• Provide GCP quality assurance and compliance support to clinical development programs to ensure clinical study and GCP compliance.
• Provide guidance for internal teams and external vendors on GCP related regulations/ guidelines including risk based quality management, and company SOPs.
• Work with internal and external study teams and vendors to develop strategic clinical quality plans.
• Identify, escalate and resolve clinical quality compliance issues within the company, as well as at clinical sites, and external vendors.
• Support the development and implementation of the QMS and develop and implement GCP SOPs.

Position Requires:

• Bachelor's Degree (minimum) and at least 5 years of pharmaceutical industry GCP / clinical quality assurance experience.
• Experience supporting Regulatory Authority Inspections.
• Experience in the use, development, and oversight of QMS.

This is a full time permanent position working a hybrid model. Only local candidates in the Boston, MA area who are willing to work partially on-site will be considered.