There is an excellent opportunity for a Lead GCP role within a Quality department for a growing and stable pharmaceutical firm located inCambridge,MA. This opportunity will give you the chance to expand on your GCP skills and mentor others within the Quality team. In addition to conducting GCP audits related to clinical safety, drug development, and pharmacovigilance, you will be identifying any opportunity to ensure GCP standards.

 Key Responsibilities Include:

Displaying coaching and mentoring abilities while building team unity

Securing the Clinical team’s commitment on action plans

Conducting GCP audits of vendors, databases, clinical labs, systems, and Clinical Investigator Sites

Identifying opportunities for GCP and news business processes to obtain high quality standards for GCP

Providing Quality management with an evaluation of all external and internal controls

Reinforcing Quality Assurance programs and providing regulatory expertise to clinical teams and customer divisions

Requirements Include:

Master’s Degree in a scientific or allied field and 3+ years of GCP and Quality Systems Auditing

Bachelor’s Degree in a scientific or allied health field and 6+ years of GCP and Quality Systems Auditing

At least 3 years of experience in a Quality Role