Director, Facilities & Equipment Quality Strategy, and Technical Oversight Support

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 T-cell 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.

The Director Facilities and Equipment Quality Strategy and Technical Oversight provides global Quality leadership for GMP facilities utilities and equipment across the company collaboration with Facilities and Engineering this role supports the definition of enterprise policies standards and strategies that ensure infrastructure and assets remain compliant reliable and fit for intended use throughout their lifecycle. The Director provides independent Quality oversight and approval guides risk-based decisions advances organizational capability drives harmonization and continuous improvement and partners with site and global functions to deliver consistent quality and regulatory outcomes.

Strategic Quality Oversight of Facilities and Equipment:

• Collaborate with Facilities and Engineering to define and maintain enterprise policies standards and strategies; provide independent Quality review and approval.
• Provide Quality oversight and approval across the facilities utilities and equipment lifecycle applying engineering standards Quality by Design principles and relevant FDA ICH and ISPE guidance.
• Ensure compliance with cGMPs company policies and regulatory requirements through risk-based oversight escalation and approval.
• Lead network-wide harmonization and continuous improvement to strengthen governance consistency compliance and reliability.
• Ensure control strategies are established maintained periodically evaluated and continuously improved.
• Serve as the global Quality subject matter expert representing Quality in governance forums and guiding risk-based decisions.
• Provide Quality oversight and approval for new process design and facility start-up.
• Oversee significant investigations corrective and preventive actions and the sharing of lessons learned across the network.
• Provide Quality oversight and approval for regulatory submissions and inspections and govern related observations and commitments through closure.

Technical Knowledge:

• Apply in-depth knowledge of U.S. and international GMP requirements standards and best practices for facilities utilities and equipment.
• Translate Quality and engineering principles into effective policies standards strategies and lifecycle controls.
• Develop risk-based solutions to complex facilities utilities and equipment quality issues where precedents may be limited.
• Analyze performance and reliability data to prioritize risks guide decisions and support continuous improvement.
• Maintain current knowledge of industry practices emerging technologies and regulatory trends affecting facilities and equipment quality and reliability.
• Build effective partnerships with Facilities Engineering Quality Manufacturing suppliers and other internal and external stakeholders.
• Communicate complex technical and Quality matters clearly to technical business and executive audiences.
• Represent Quality effectively in regulatory interactions involving facilities utilities and equipment.

Cross-Functional Collaboration:

• Partner with Global Quality Facilities and Engineering to define implement and maintain facilities utilities and equipment quality programs.
• Ensure local and global Quality decisions are risk-based documented traceable and aligned with company processes.
• Build network capability through knowledge programs communities of practice and mentoring stakeholder subject matter experts.
• Collaborate across Engineering Facilities Manufacturing and other functions to meet quality requirements and business objectives.
• Communicate decisions risks and recommendations clearly to senior leaders and stakeholders at all levels.
• Provide leadership and guidance that reinforces a culture of quality compliance accountability and continuous improvement.

Basic Qualifications:

• PhD with 8years of relevant experience in facilities management engineering quality assurance or a related field within a regulated environment OR
• Masters degree with 10years of relevant experience in facilities management engineering quality assurance or a related field within a regulated environment OR
• Bachelors degree with 12years of relevant experience in facilities management engineering quality assurance or a related field within a regulated environment OR
• Associates degree with 14years of relevant experience in facilities management engineering quality assurance or a related field within a regulated environment OR
• High School Degree with 16 years of relevant experience in facilities management engineering quality assurance or a related field within a regulated environment.

Preferred Qualifications:

• Demonstrated knowledge and application of scientific engineering and Quality principles across the lifecycle of facilities utilities and equipment in a regulated manufacturing environment.
• Experience providing Quality oversight for the commissioning qualification and validation of facilities utilities and equipment.
• Experience leading global cross-functional teams programs or initiatives involving facilities utilities and equipment quality.
• Experience applying reliability engineering and risk-based principles to pharmaceutical or similar manufacturing assets.
• Experience with cell and gene therapy manufacturing and associated facilities utilities and equipment requirements.
• In-depth knowledge of regulations and industry expectations applicable to cell and gene therapy facilities utilities and equipment.
• Relevant professional certification such as CQE or CQA.

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams modeling inclusion and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills experience aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow develop and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals purpose and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

The salary range for this position is: $191250.00 - $247500.00. 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:

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 systems ability to recognize and kill 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:

Kite Pharma 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 non-job related characteristics or other prohibited grounds specified in applicable federal state and local 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

Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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.

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

Please apply via the Internal Career Opportunities portal in Workday.