Associate Director, Quality Management Systems (Remote)

Overview

The QMS Associate Director oversees Quality Management System topics within the Quality Compliance Organization at Organon, focusing on creating a user-centric global QMS and ensuring compliance with GMP training and inspection readiness.

In Short

• Oversee Quality Management System implementation and compliance.
• Support business owners of EtQ modules within the QMS.
• Ensure inspection readiness for Medical Devices.
• Collaborate across functions to drive continuous improvement.
• Develop and maintain metrics for QMS evaluation.
• Lead cross-functional teams in QMS topic development.
• Monitor global regulations impacting QMS topics.
• Provide leadership on regulatory requirements.
• Conduct gap assessments for inspections.
• Drive the development of permanent inspection readiness.

Requirements

• Degree in Life Sciences, Engineering, or related discipline.
• 8+ years in FDA/EU regulated pharmaceutical environment.
• Experience in quality roles within manufacturing sites.
• Strong knowledge of global health authority regulations.
• Excellent project management and communication skills.
• Ability to lead multiple projects simultaneously.
• Innovative mindset for quality improvement.
• Strong collaboration and leadership skills.
• Ability to influence and drive change.
• Proven ability to communicate effectively at all levels.

Benefits

• Retirement savings plan.
• Paid vacation and holidays.
• Paid caregiver/parental and medical leave.
• Health benefits including medical, dental, and vision coverage.