Job Description

Position Summary

Provide strategic leadership for Quality Assurance programs across U.S. operations, ensuring compliance with applicable global regulations and industry standards. This role is responsible for driving quality excellence, regulatory readiness, and continuous improvement across research, development, clinical, and manufacturing activities.

Responsibilities

• Provide strategic and scientific leadership for the organization’s Risk-Based Quality Management System (QMS).
• Lead and oversee Quality Assurance functions supporting R&D, Clinical, CMC, and Manufacturing operations.
• Direct GxP compliance activities and lead regulatory inspections, including interactions with global health authorities.
• Drive execution of the company’s global QA strategy in alignment with established quality standards and policies.
• Establish, govern, and monitor global quality processes and procedural frameworks.
• Identify and implement quality improvement initiatives based on compliance trends, metrics, and industry benchmarks.
• Serve as a subject matter expert in GxP principles and quality systems.
• Maintain current knowledge of regulatory expectations, industry trends, and best practices.
• Oversee development and delivery of internal and external GxP training programs.
• Collaborate with internal and external stakeholders, regulatory agencies, and strategic partners to support organizational objectives.

Qualifications

• Advanced degree preferred; Bachelor’s degree required.
• 15+ years of experience in the pharmaceutical or biotechnology industry.
• Proven leadership experience managing cross-functional Quality Assurance teams.
• Deep knowledge of R&D QA, GLP, CMC, and Manufacturing QA environments.
• Strong understanding of global regulatory requirements, including GMP and regulatory inspections.
• Demonstrated expertise in Quality Management Systems and compliance frameworks.
• Experience supporting complex, multi-site, or international organizations preferred.
• Strong strategic thinking, communication, and stakeholder management skills.
• Ability to lead large-scale programs, initiatives, and organizational change.

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