Description:

Oversee, implement, and improve GCP quality systems for global clinical operations, including decentralized clinical trials (DCTs).
Ensure compliance with ICH GCP, global regulatory requirements, and internal Quality Management System (QMS) processes.

Requirements:

Bachelor's Degree or higher in pharmaceutical, life sciences, or engineering.
3 to 5 years of experience in a quality-related role within a CRO, pharmaceutical, biotechnology, or healthcare organization.
Experience with global clinical trials and decentralized clinical trial activities.
Knowledge of GCP regulations and global regulatory expectations, including ICH E6(R3), FDA, and EU Clinical Trial Regulation.
Strong analytical, organizational, communication, and stakeholder management skills.

Medical, dental, and vision insurance.
401K safe harbor plan with company match, paid vacation, holiday, sick, and volunteer time.

Benefits