GxP Quality Operating Model Process Lead - Remote

Overview

The GxP Quality Operating Model Process Lead will support the development, implementation, and sustainability of the GxP Quality Operating Model with a focus on governance, process architecture, and cross-functional collaboration.

In Short

• Lead the development and execution of a GxP Quality Operating Model governance forum.
• Manage the integration of GxP process architecture across collaborators.
• Collaborate with Global Quality to define the role of global process owners.
• Drive training initiatives for awareness of GxP QOM.
• Develop and maintain the GxP Quality Manual.
• Support continuous improvement of integrated GxP process architecture.
• Foster collaboration across various GxP Quality domains.
• Define critical metrics for the health of the quality system.
• Lead organizational design around GxP GPO function.
• Inspire a connected and inclusive work environment.

Requirements

• Doctorate degree and 3 years of related experience, or equivalent qualifications.
• Strong understanding of R&D and operations within the PhRMA/Biotech sector.
• Experience in leading large-scale initiatives.
• Exceptional communication and persuasive skills.
• Ability to work independently and adapt to change.
• Understanding of the legal and regulatory environment affecting PhRMA/Biotech.
• Experience fostering creativity and innovation.
• Outstanding oral and written communication skills.

Benefits

• Comprehensive employee benefits package.
• Retirement and Savings Plan with generous contributions.
• Flexible work models, including remote options.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Group medical, dental, and vision coverage.
• Career development opportunities.
• Award-winning time-off plans.