Senior Manager, GCP QA Operations

Overview

In this role you will drive GCP quality assurance across global clinical development programs. You will partner with multifunctional study teams to sustain regulatory compliance and foster quality decision-making. You’ll lead quality oversight, risk-based planning, and inspection readiness activities to support study start-up through regulatory inspections. This position integrates QA leadership with continuous process improvement to ensure high-quality research outcomes. You will engage with internal and external stakeholders to implement corrective actions and strengthen quality systems.

Responsibilities

• Ensure GCP and regulatory compliance for assigned studies and programs
• Provide quality oversight and standardize operational methods
• Act as a quality partner to cross-functional study teams
• Monitor quality performance and drive improvement initiatives
• Review quality agreements and vendor contracts for compliance
• Support clinical quality plans and risk-based approaches
• Contribute to inspection readiness activities and assist during inspections
• Collaborate to address compliance issues and implement CAPA
• Promote continuous process improvement of clinical and medical quality systems
• Develop and communicate corporate quality objectives related to clinical research

Key requirements

• Strong knowledge of GCP, GVP, and GPP
• Experience managing interventional and non-interventional studies
• Proven problem-solving and solution development abilities
• Excellent interpersonal, leadership, and matrix-organization collaboration skills
• Strong customer focus and ability to influence cross-functional teams
• Proficiency in English (written and spoken)
• Master in Science or higher in a relevant scientific field; PhD or quality-focused degree preferred

• interpersonal skills
• leadership
• collaboration
• GCP
• GVP
• GPP

…