Kite Pharma · 14 hours ago
Associate Director, Global Quality Systems - Document Control and Training
Santa Monica, CA
Full-time
Onsite
Lead/Staff, Director/Executive
$154K/yr - $199K/yr
8+ years expKite Pharma is a biopharmaceutical company dedicated to curing cancer through innovative therapies. The Associate Director of Global Quality Systems will establish and oversee the Document Control and Training Programs, ensuring compliance with regulations and enhancing training systems to meet evolving business needs.
BiotechnologyHealth CareMedicalOncologyTherapeutics
Responsibilities
Develop and implement the strategy for Document Control and Training processes to drive sustained compliance of cGMP/GDP activities
Develop and implement comprehensive Global Document Control and Training processes, including policies, procedures, and systems
Own the technical content and sustainability of the Document Control and Training processes, including the Policy, Standards, Standard Operating Procedures, and associated business enabling documents
Establish and maintain a framework for document management and training delivery including creation, review, approval, revision, storage, and obsolescence
Ensure that the processes 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 Document Control and Training processes
Establish and monitor key performance indicators (KPIs) to assess process effectiveness
Conduct regular audits and assessments to ensure compliance with internal and external requirements
Identify and mitigate risks associated processes
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 electronic document management (Veeva) and learning management systems
Ensure systems meet the needs of the organization and supports efficiency and agility
Manage system access, security, and data integrity
Develop and deliver training programs on process policies and procedures
Promote a culture of quality and compliance across the organization
Communicate 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 document control and training needs are met
Partner with senior management to align processes with business objectives
Manage relationships with external vendors and service providers
Monitor industry trends and best practices in document control and training
Identify opportunities for process improvement and innovation
Implement changes to enhance the efficiency and effectiveness of the document control and training processes
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
10+ years of experience in the pharmaceutical and/or biotechnology industry operating within, or managing, a global document control network
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