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

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

We are seeking a Director for a Facilities & Equipment Quality Oversight Support role. The role is a critical leadership role responsible for establishing, implementing, and maintaining global quality standards and processes for all company facilities and equipment. Serving as the primary point of contact and decision-maker for internal policies, procedures, and strategy documents governing the quality of facilities and equipment across the global network, this role will ensure robust and compliant infrastructure and assets. The Director will support knowledge advancement across the organization, drive process improvements and harmonization, represent the company in relevant industry forums, and partner with global quality functions to ensure consistent and high-quality standards.

Strategic Quality Oversight of Facilities and Equipment:

• Serve as the primary global point of contact and decision-maker for internal policies, procedures, and strategies governing facilities and equipment quality oversight.

• Provide strategic quality oversight for the design, installation, commissioning, qualification, and validation of facilities, equipment, and utilities, leveraging engineering standards, Quality by Design principles, and experience aligned with FDA, ICH, & ISPE guidelines.

• Ensure all activities comply with current Good Manufacturing Practices (cGMPs), company policies, and regulatory requirements.

• Sponsor and oversee process improvements and harmonization projects across the network for facilities and equipment quality.

• Ensure robust and consistent control strategies for facilities and equipment are maintained for valuation and continuous improvement, meeting regulatory and compliance expectations.

• Serve as the SME leader for facilities and equipment quality across the network, representing on relevant teams and governance forums.

• Provide technical support during new process design and facility start-up to ensure site facilities and equipment quality programs and product requirements are met.

• Provide technical support for investigations related to facilities and equipment quality to identify root causes and implement corrective actions, sharing best practices/learnings/CAPAs across the network.

• Support regulatory submissions and on-site inspections related to facilities and equipment; define and execute the process for managing network observations and commitments.

Technical Knowledge:

• Demonstrate in-depth understanding and application of GMP principles, concepts, best practices, and standards (US and international) specific to facilities and equipment.

• Ability to develop and improve complex concepts, techniques, standards, and new applications for facilities and equipment based on quality principles.

• Ability to develop innovative solutions to complex facilities and equipment quality problems where precedents may not exist.

• Proficiency in data analysis of facility and equipment performance, prioritization, attention to detail, critical decision-making, and complex problem-solving.

• Demonstrate extensive knowledge of industry best practices and trends in facilities and equipment quality and reliability.

• Experience building effective working relationships across all internal and external stakeholders impacting facilities and equipment quality.

• Demonstrate excellent verbal, written, and interpersonal communication skills.

• Comfortable interacting with regulatory agencies on facilities and equipment topics.

Cross-Functional Collaboration:

• Partner with Global Quality to support the development, implementation, and oversight of facilities and equipment quality programs.

• Ensure local and global quality decisions related to facilities and equipment are applicable, docume