- Ensure that the document management, change management, and other Quality System programs are maintained and administered in a manner that maximizes efficiency, complies with industry standards, and achieves desired strategic goals.
- Initiate the development and implementation of quality system improvements programs across Adaptimmune
- Define the global strategy for the development of GxP policies and procedures in support several company-wide programs.
- Manage a team of document control and quality systems specialist in the administration of GxP related documents.
- Lead backroom support during regulatory and/or partner inspections and assist with the development of responses to questions and/or findings.
- Oversee the day-to-day the management of the Change Management system.
- Provide subject matter expertise to assure deviations, CAPA and change control records meet regulatory requirements and industry practices
- Oversee the management and administration of the GxP electronic quality management systems
- Provide the necessary support in troubleshooting quality and system related issues received from end users on a timely manager
- Provide the necessary support to other members of the quality team and organization in preparation of metrics for management review and escalation of issues
Qualifications & Experience
- Minimum Bachelor’s Degree in any scientific discipline
- Minimum of 8 years of relevant experience including a minimum of 3 years of management experience in a regulated environment focused on quality.
- Experience in managing a team of quality professionals
- Ability to manage multiple projects in a fast-paced environment.
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
- Ability to understand when issues require escalation to the Head of Quality Systems.