Associate Director responsible for overseeing Global Change Management at Kite Pharma. Leading compliance and continuous improvement in change processes for innovative cancer therapies.
Responsibilities
Develop and implement the strategy for Change Management to drive sustained compliance of cGMP activities
Develop and implement a comprehensive global Change Management program, including policies, procedures, and systems
Own the technical content and sustainability of the Change Management topic, including the Policy, Standards, Standard Operating Procedures, and associated business enabling documents
Establish and maintain a framework for change creation, review, approval, revision, and governance
Ensure the program aligns with relevant regulations (e.g., FDA, ISO), industry standards, and business needs
Lead continuous improvement efforts and remaining current with regulatory changes and industry best practices
Provide strategic direction and oversight for the Global Change Management program
Establish and monitor key performance indicators (KPIs) to assess program effectiveness
Conduct regular audits and assessments to ensure compliance with document control requirements
Identify and mitigate risks associated with change management
Manage interdependencies within and across QMS Topics
Provide leadership and technical direction for their Topic and associated support systems across a Global network
Oversee the selection, implementation, and maintenance of Change Management systems (Veeva)
Develop and deliver training programs on supporting Change Management policies and procedures
Promote a culture of quality and compliance across the organization
Requirements
PhD with 2+ years of related experience in a biologics or pharma organization OR MS/MA with 8+ years of related experience in a biologics or pharma organization OR BS/BA with 10+ years of related experience in a biologics or pharma organization
High School diploma with 14+ years of related experience in a biologics or pharma organization
6+ years of experience in the pharmaceutical and/or biotechnology industry providing change management and direct strategic oversight of change management for a Quality or Manufacturing oriented group
Experience with Veeva eDMS is preferred
Benefits
Health insurance
Paid time off
Discretionary annual bonus
Discretionary stock-based long-term incentives
Benefits package
Job title
Associate Director, Global Quality Systems – Change Management
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