Address
Form of workProduct Variation Management (PVM) Lead will manage the business and system processes for managing product variations. As Kite expands to more products, global jurisdictions and manufacturing sites, changes increase in complexity and the number of product lifecycle changes that require variation management and jurisdictional control (JC) is proliferating. The PVM Lead will manage the global cross functional PVM team and JC business processes, and ensure, from an end-to-end planning and execution perspective, that the right product version is supplied to the right jurisdiction at the right time, in line with the regulatory filing strategy and global implementation plan. The product variation planning process is complex and oversees changes end-to-end, from regulatory filing to global and regional planning, and to manufacturing site implementation.
Responsibilities (include but are not limited to):
• Lead a cross-functional matrix global PVM planning team that spans across all Technical Operations functions, IT, and Clinical Logistics
• Own and manage the business process for managing product variations
• Manage change management and communication of the new business process
• Lead team meetings, manage the global PVM tracking tools, and monitor PVM and JC metrics
• Responsible for overseeing product variations from strategy definition through implementation across all impacted jurisdictions and manufacturing sites
• Collaborate with cross functional stakeholders globally, considering interdependencies across Tech Ops, manufacturing network, and other stakeholders as needed
• Facilitate cross-functional SME assessment of product variation changes to determine the plan for implementation
• Liaise between the global PVM planning team and the governance bodies responsible for product variation and lifecycle management strategy definition, for alignment between strategy and implementation rollout plan
• Deep dive into functional areas and manufacturing site processes to understand complexities, interdependencies, risks, and facilitate alignment across functions
• Monitor status of change control(s) enabling a variation’s implementation globally from initiation to approval to implement; change control ownership possible based on type of change
Requirements:
• BS degree required, concentration in science / engineering / business management is a plus
• Master's Degree and 3-5 years of operations or supply chain experience in life sciences industry or Bachelor's Degree and 5-7 years of operations or supply chain experience in life sciences industry
• Experience in working with ERP business systems (preferably Oracle EBS)
• Diverse experience in operations disciplines
• Exceptional ability to communicate and collaborate across different stakeholders
• Ability to operate at different levels, both strategically and tactically
• Proven success in leading cross functional teams and ability to influence all levels of staff in a matrix organization
• Experience in Project Management and / or with PM tools such as SmartSheet is a plus
• Drive to seek clarity and think critically
• Excellent verbal, and written communication skills, including presentations
• Ability to manage ambiguity and simplify complexity
• Ability to navigate competing interests to achieve a common solution that is aligned across different parties
• Ability to learn quickly, and absorb and simplify information from multiple sources; “connect the dots” into a cohesive plan
• Self-directed and able to work independently with minimal direction
• Works well in a dynamic, fast-changing environment
• Enthusiastic team player
Hybrid:3 days onsite, Santa Monica
Hours: Flexible
