Kite Pharma · 13 hours ago
Assoc Director, Global Quality Systems - Change Management
Santa Monica, CA
Full-time
Onsite
Director/Executive
$165K/yr - $214K/yr
8+ years expKite Pharma is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies. The role of Assoc Director, Global Quality Systems - Change Management involves establishing and overseeing Kite’s Global Change Management program to ensure compliance with regulations and continuous improvement of change management processes.
BiotechnologyHealth CareMedicalOncologyTherapeutics
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
Ensure alignment with applicable regulations (e.g., FDA, ISO), internal policies, and business needs
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)
Ensure system meets the needs of the organization and supports efficient and compliant workflows
Develop and deliver training programs on supporting Change Management policies and procedures
Promote a culture of quality and compliance across the organization
Communicate Change Management program updates and changes to stakeholders
Promote a Culture of Quality and Compliance across the network
Communicate and collaborate with stakeholders on Topic updates and changes
Collaborate with cross-functional teams (e.g., Quality, Regulatory, Operations, R&D) across a global network, to ensure process needs are met
Partner with senior management to align the Change Management program with business objectives
Manage relationships with external vendors and service providers
Monitor industry trends and best practices in Change Management
Identify opportunities for process improvement and innovation
Implement changes to enhance the efficiency and effectiveness of the Change Management program
Qualification
Required
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
Preferred
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
Excellent communication and influencing skills
Proven ability to work and influence across a global network
Ability to collaborate and work cross-functionally
Creative problem solving approach and solutions based mindset
Ability to provide cross-functional leadership
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans
Company
Kite Pharma
Kite Pharma is a biotechnology company that designs and develops immune-based therapies to treat cancer indications.
1001-5000 employees
H1B Sponsorship
Kite Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (54)
2024 (47)
2023 (54)
2022 (59)
2021 (53)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$335.38MKey Investors
Alta Partners
2017-08-28Acquired
2015-12-10Post Ipo Equity· $250.12M
2014-06-20IPO
Leadership Team
Craig Vermeyen
Director, Packaging and Labeling
Mark Jurgens
Executive Director, Head of External Scientific Collaboration
Recent News
BioWorld Financial Watch
2025-12-29
2025-12-07
Company data provided by crunchbase