What are the responsibilities and job description for the Senior Manager, QA - GCP Audit Management position at Proclinical?
Senior Manager for QA - Permanent - Cambridge, MA
Proclinical is seeking a dedicated Senior Manager for QA in GCP Audit Management.
Primary Responsibilities :
The successful candidate will focus on ensuring compliance with FDA and international regulations for clinical studies. You will be instrumental in vendor risk assessment, audit management, and developing quality metrics. This position offers the opportunity to contribute significantly to inspection readiness and audit coordination.
Skills & Requirements :
- Degree in a scientific discipline; advanced degree preferred.
- Experience in Quality Assurance roles, including GLP / GCP / GVP audits.
- Knowledge of global clinical trial conduct and regulatory guidelines.
- Experience in supporting regulatory authority inspections.
- Strong interpersonal skills and ability to work cross-functionally.
- Willingness to travel up to 25% domestically and internationally.
The Senior Manager for QA's responsibilities will be :
