Director, Quality Systems: Quality Process Owner – Data Integrity

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

Everyone at Kite is united by one common goal: curing cancer. We strive every day to connect this purpose to our work. Join us in making a difference!

We are seeking an experienced Quality Process Owner of Data Integrity (DI) to oversee our Data Integrity processes and controls that span an international GMP manufacturing network. Acting as an individual contributor, leading through a matrixed network team this position will play a critical role in defining global standards, procedures and protocols and ensuring Kite’s processes are in compliance with EU, US, and international regulations. The role involves establishing an aligned global DI foundation for the organization and working with local sites and functions to drive compliance, enhancing awareness, and managing data integrity risks.

This position is essential for upholding our standards for data integrity processes and ensuring we remain at the forefront of quality and compliance in the cell therapy industry. We invite you to bring your expertise, passion for innovation, and commitment to quality to help us advance Kite’s mission.

Responsibilities include but are not limited to:

• Develop, update, and maintain a suite of comprehensive Data Integrity procedures and protocols that comply with international, EU, and US regulations. This includes interpreting regulatory requirements and changes to regulations to ensure processes and procedures are compliant with current regulatory expectation
• Establish a foundation for consistent data integrity processes across all manufacturing sites and systems to ensure uniformity in practices, tools, and methodologies used for data management.
• Critical Focus: Data generation using validated systems in controlled environments, user access controls, audit trail availability and review, data retention, backup, and recovery
• Establish strategies for ensuring data flow mapping across systems is conducted to maintain integrity from source to analytics, verifying control points, quality checks, and documentation of transformations for compliance and accuracy.
• Act as a subject matter expert supporting site adherence to data integrity standards when potential vulnerabilities are identified in systems and processes.
• Assist in the creation and delivery of training programs to educate employees on data integrity principles, compliance requirements, and the importance of data accuracy and security.
• Establish metrics and reporting tools to track performance indicators related to data integrity.
• In collaboration with site Quality ensure that all data systems and processes are audit-ready by maintaining proper documentation, records, and by preparing teams for internal and external audits.
• Ensure that data integrity considerations are embedded into all relevant business processes helping to ensure seamless integration of defined standards without compromising efficiency.
• Work closely with site and network teams in IT, OT, Quality Assurance, Regulatory Affairs, and Manufacturing to align data integrity best practices with broader business goals and regulatory requirements.
• Champion a culture of continuous improvement in data integrity practices, leveraging feedback from audits, industry trends, and technological advancements to enhance data management strategies.
• Keep abreast of evolving regulations and industry standards concerning data integrity, representing the company in industry forums or regulatory discussions when relevant.
  

Basic Qualifications:

• PhD in information systems, engineering or related field with 8 years of relevant experience in application of GMP Quality Assurance, with specific experience in quality engineering, validation, computer system validation, quality technical management or similar disciplines OR
• Master’s degree in information systems, engineering or related field with 10 years of relevant experience in application of GMP Quality Assurance, with specific experience in quality engineering, validation, computer system validation, quality technical management or similar disciplines OR
• Bachelor’s degree in information systems, engineering or related field with 12 years of relevant experience in application of GMP Quality Assurance, with specific experience in quality engineering, validation, computer system validation, quality technical management or similar disciplines OR
• Associate’s degree in information systems, engineering or related field with 14 years of relevant experience in application of GMP Quality Assurance, with specific experience in quality engineering, validation, computer system validation, quality technical management or similar disciplines OR
• High School Degree with 16 years of relevant experience in application of GMP Quality Assurance, with specific experience in quality engineering, validation, computer system validation, quality technical management or similar disciplines.
  
  

Additional Qualifications:

• Proficiency in quality management systems and technologies used to ensure data integrity, including ERP systems, LIMS, electronic batch records, and other data management tools.
• Familiarity with IT systems and their integration into manufacturing and quality processes from a data integrity perspective.
• In-depth understanding of data integrity regulations and guidelines from various regulatory bodies such as the FDA, EMA, MHRA, PhMDA, etc (21 CFR Part 11, Annex 11, etc.).
• Any additional training or certification in data governance or data privacy is beneficial.
• Adaptability to regulatory changes and technological advancements in data management.
• Willingness to travel internationally as required to oversee and support data integrity initiatives at various manufacturing sites (~20%).
• Knowledge of data privacy laws and how they intersect with data integrity in a regulated industry.
• Exceptional leadership abilities to drive initiatives across matrixed teams without direct reporting accountability.
• Strong analytical and problem-solving skills to address complex data integrity issues.
• Excellent communication and interpersonal skills to influence and educate at all organizational levels.
• Ability to lead collaboratively in a cross-functional environment, bridging gaps between IT, quality, regulatory, and manufacturing teams.
• Strategic thinking with the ability to foresee potential data integrity challenges and proactively address them.
• Detail-oriented with a commitment to maintaining high standards of data accuracy and reliability.
  
  

The salary range for this position is: $191,250.00 - $247,500.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
  
  

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.