Executive Director, QA Compliance Job at Neurocrine Biosciences, San Diego, CA

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  • Neurocrine Biosciences
  • San Diego, CA

Job Description

Neurocrine Biosciences seeks an Executive Director of QA Compliance to lead strategic oversight of quality compliance, regulatory readiness, and risk management programs across GxP activities. The role provides advisory support to senior leadership on complex compliance matters and directs a team focused on sustained regulatory compliance and continuous improvement.

Responsibilities

  • Establish multi-year compliance strategies, priorities, and operating plans aligned with company goals
  • Lead external audit program and develop risk-based audit strategy for GxP vendors and service providers
  • Own supplier quality management system, vendor agreements, qualification, and requalification programs
  • Lead internal audit program and establish risk-based audit strategy across applicable GxP systems
  • Oversee inspection readiness programs and manage regulatory inspection coordination and response

Requirements

  • Extensive experience in quality compliance and GxP regulatory environments
  • Demonstrated expertise in vendor/supplier quality management and audit programs
  • Strong knowledge of FDA regulations, GMP requirements, and inspection readiness
  • Proven track record leading cross-functional teams and quality organizations
  • Experience with internal audit programs, risk management frameworks, and recall procedures
  • Strategic leadership capability with ability to translate compliance requirements into business objectives

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