Essential Responsibilities
You will help to structure ways of working within our group, ensuring accurate reporting and resource allocation. You will be working within a tightknit multidisciplinary team, joining us as we begin to ramp up manufacturing across legacy and new product lines.
This is an excellent opportunity to work in the dynamic and fast-growing Cell and Gene therapy space, with the resources of a global company at your disposal.
•Leading cross-functional program activities for Cell and Gene Therapy projects with responsibility for timely execution within budget and in compliance with Quality procedures.
•Working closely with Product Management team to drive product direction and resolve issues
•Defining, managing and optimizing project plans, product/project risk, project budgets, and resources/task assignments to meet business goals.
•Working closely with all support functions, proactively anticipating challenges and effectively facilitating cross-functional decision making to deliver effective and timely improvements to existing products and processes.
•Maintaining a professional rhythm within both R&D and cross functional groups to deliver on the projects.
•Liaising with and working with Suppliers and our CMO to ensure seamless production and maintenance of quality.
•Reporting and tracking project resources and budget allocation, both internally and within subcontractors.
•Ensuring compliance with Product Lifecycle Process/Design History File (DHF) and other Quality Management System (QMS) requirements.
•Managing customer critical-to-quality (CTQ) objectives, regulatory requirements, schedules, and program risks and making decisions based on business objectives
•Effectively communicate across functional departments and provide periodic stakeholder communications and escalating concerns and issues as necessary
Quality Specific Goals:
•Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
•Complete all planned Quality & Compliance training within the defined deadlines.
•Identify and report any quality or compliance concerns and take immediate corrective action as required