Director Quality Systems Quality Process Owner Data Integrity

Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR Tcell therapies have changed the paradigm. But were 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 Kites 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 Kites mission.

The Quality Leadership Team is open to considering applicants from other regions and for the role to be performed remotely.

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 auditready 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 8yearsof 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

• Masters degree in information systems engineering or related field with 10yearsof 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

• Bachelors degree in information systems engineering or related field with 12yearsof 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

• Associates degree in information systems engineering or related field with 14yearsof 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 yearsof 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.

• Indepth 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 problemsolving 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 crossfunctional 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.

• Detailoriented with a commitment to maintaining high standards of data accuracy and reliability.

For additional benefits information visit:

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 longterm 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 systems ability to recognize and tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob related characteristics or other prohibited grounds specified in applicable federal state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections please view theKnow Your Rights poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.