Therapeutic Area Quality Lead (GCP)

GlaxoSmithKline; Waltham (MA); On-site; USD 210,000 - 349,000; Full time

Benefits offered by this job

Health care benefits

Retirement benefits

Paid holidays

Parental leave

Job summary

GSK is seeking a Team Lead, Therapeutic Area Quality (GCP/Clinical Quality) to guide a team of Quality Business Partners delivering independent GCP quality oversight across trials and R&D programs. This leader helps design quality into development plans and ensures readiness for submissions and inspections.

The role requires a strong track record in GCP, international collaboration, and managing quality assurance activities, with opportunities to influence regulatory interactions and drive

Qualifications

• Bachelor's degree or equivalent in a scientific or quality-related field.
• Demonstrated expertise in Good Clinical Practice (GCP) and clinical trial quality oversight.
• Experience in pharmaceutical industry and/or clinical quality assurance.

Responsibilities

• Lead a team of QBPs providing GCP quality oversight.
• Ensure quality activities are integrated into development programs.
• Support health authority inspections and due diligence as needed.

Skills

GCP expertise

Quality oversight

Leadership

Global collaboration

Risk management

Education

Bachelor's degree

Tools

Veeva QMS

CTMS

Job description

GSK is seeking a Team Lead, Therapeutic Area Quality (GCP/Clinical Quality) to guide a team of Quality Business Partners delivering independent GCP quality oversight across trials and R&D programs. This leader helps design quality into development plans and ensures readiness for submissions and inspections.

The role requires a strong track record in GCP, international collaboration, and managing quality assurance activities, with opportunities to influence regulatory interactions and drive