Quality Lead: GCP

Lead Specialist - GCP

A very reputable and growing client of mine inCambridge,MAis actively looking for a Quality Lead - GCP/PV Auditing. The Quality Lead of Quality Compliance Management (QCM) will be responsible for developing the GCP external and internal audit program. In this role, you will be building team unity, ensure compliance with company's procedures, and influence the decision making process. This position offers incredible career growth, generous compensation, and a great work environment.

Key Responsibilities Include:

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

Secure the clinical team's commitment on action plans

Provide regulatory expertise and process optimization to customer divisions, clinical teams, and conducting field interaction to reinforce QA Programs

Identify opportunities for GCP and business process and internal/external controls to assure high quality standards for GCP systems/processes and clinical safety and pharmacovigilance compliance with policies and regulations

Developing audit reports, coordinating action plans and following up with auditees to assure timely completion of agreed upon actions

Actively contruibute to the development of clinical research, safety and clinical quality and compliance systems and standards

Develop activities related to GCP audit program, GCP Training, Audit/Inspection Support, and collaborating with Global Patient Safety

Reporting of Pharmacovigilance compliance metrics related to QCM internal audit activities

Requirements Include:

Master's degree in a scientific or allied health field and 3+ years of GCP and/or PV Auditing work

Bachelor's degree in a scientific or allied health field and 6+ years of GCP and/or PV Auditing Work

3+ years of experience in a Quality Role

To find out more about Real Staffing please visit www.realstaffing.com