This is a fully remote position, open to applicants in California.

📋 Description

• Overseeing the management of escalated GxP and Quality incidents through a comprehensive end-to-end process at a global scale.

• Implementing measures to prevent GxP/Quality incidents.

• Maintaining and continuously enhancing defined processes related to incident management within regulated environments on a global level.

• Leading and ensuring the effective management of quality incidents.

• Guaranteeing adherence to regulatory requirements (e.g., ICH Q9).

• Developing and expanding knowledge management processes and tools to facilitate quick access to data and information throughout the entire product lifecycle.

⛳️ Requirements

• A Bachelor’s degree along with over 8 years of experience in quality sciences, quality systems, or related disciplines within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices).

• A Master’s degree with a preferred 10+ years of direct experience.

• At least 6 years of managerial experience directly supervising personnel and/or leadership experience in guiding teams, projects, programs, or directing resource allocation.

• Strong proficiency in PC applications is essential; MS Office skills (Outlook, Word, Excel, PowerPoint) are required.

• Experience in regulatory interactions, including notifications and communications with health authorities on a global scale concerning sensitive compliance issues.