Associate Director GCP Quality Assurance

Associate Director GCP Quality Assurance

Base pay range

$180,000.00 / yr - $210,000.00 / yr

Associate Director, GCP Quality Assurance

Location : SF Bay Area – 5 days onsite

Overview

The Associate Director, GCP QA plays a key role in driving consistency across Quality systems and processes supporting Clinical programs. This role partners closely with GCP QA and Clinical Operations Quality Management to support day-to-day clinical trial activities, including deviations, investigations, audit findings, and CAPA management. The position also contributes to inspection readiness efforts and provides cross-functional guidance on compliance and quality expectations.

Key Responsibilities

• Lead alignment and oversight of Quality Systems across Clinical QA.
• Assess current processes, identify gaps, implement improvements, and monitor GCP-related Quality Systems.
• Develop and manage reports tracking key GCP and Clinical Quality metrics.
• Review and approve deviations and CAPAs.
• Partner with Regulatory, Clinical Operations, and other stakeholders on compliance issues.
• Maintain up-to-date knowledge of Health Authority regulations and advise Clinical teams on impacts.
• Represent Clinical QA in internal presentations and quality initiatives.
• Identify and escape risks, proposing practical solutions.
• Contribute to process and system improvement activities.

Education & Experience

Seniority level

Director

Employment type

Full-time

Job function

Quality Assurance

Industries

Staffing and Recruiting, Pharmaceutical Manufacturing, and Biotechnology Research

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