Head of Japan cell therapy external supply managing clinical and commercial products for BMS. Leading cross - functional matrix team for reliable supply and performance within external network.
About the role
- 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
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