Senior/Executive Director, Quality Management System

Role Overview

The Senior/Executive Director, Quality Management System (QMS) will be responsible for driving and delivering the activities necessary to develop, implement, and continuously improve a phase appropriate GxP QMS. This role will be directly involved with both strategy development and day-to-day tactical execution related to QMS processes such as Document Management, Training Management, Change Control, Management Review (MR), Annual Product Quality Review (APQR), Deviation, CAPA, Risk Management, and GxP Computer System Assurance.

The Sr./Exec. Director will be responsible for the maintenance of both paper-based and electronic processes and lead quality initiatives to support the pace and growth of the organization.

This role will maintain and ensure effectiveness of quality programs and documentation to assure compliance and inspection readiness with all applicable quality requirements and regulatory standards.

The ideal candidate brings hands-on expertise in creating and maintaining a GxP QMS, a proactive approach to problem-solving, and the ability to guide and influence cross-functional teams while upholding the highest standards of quality and compliance.

Key Responsibilities

• Select, implement, manage, and oversee GxP electronic systems including any associated Purchase Orders and contracts.
• Develop, implement, manage, continuously improve, and oversee processes such as Document Management, Training Management, Change Control, Management Review (MR), Annual Product Quality Review (APQR), Deviation/CAPA/ Risk Management, and GxP Computer System Assurance
• Guide and support GxP process owners with implementation and improvement /optimization of key functional area processes
• Establish and improve policies and standard operating procedures for efficient and compliant management of GxP QMS processes
• Establish, track and report quality metrics for QMS processes and present improvement opportunities at Management Review meetings
• Implement phase appropriate, risk-based, fit-for-purpose approaches to QMS processes
• Ensure that QMS processes comply with phase applicable regulatory standards, regulations and guidelines.
• Maintain awareness of new regulations, technologies, industry trends and best practices and apply them as may be relevant
• Manage resources to achieve company, department and functional area goals and objectives
• Contribute to the development and maintenance of a positive team-focused company culture
• Provide coaching as a manager and team member, make quality decisions and be Quality Approver as appropriate