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

Kite Pharma, Inc.; Santa Monica (CA); Hybrid; USD 191,000 - 248,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Job summary

Kite Pharma, Inc. seeks a Director of Facilities & Equipment Quality Strategy & Technical Oversight to lead global quality for GMP facilities, utilities, and equipment.

You will collaborate with Facilities, Engineering, and Quality to define strategies and ensure lifecycle controls and regulatory compliance. The role requires in-depth GMP knowledge, strategic oversight, and the ability to drive risk-based decisions across a global network, including regulatory submissions and inspections

Qualifications

• PhD or advanced degree with extensive GMP facilities experience.
• Experience leading global cross-functional teams.
• Experience with commissioning, qualification, and validation.
• Knowledge of cell and gene therapy manufacturing.

Responsibilities

• Provide global Quality leadership for GMP facilities, utilities, and equipment across the network.
• Oversee significant investigations, CAPA, and lessons learned sharing across the network.
• Provide Quality oversight and approval for regulatory submissions and inspections and govern related commitments.

Skills

GMP knowledge

Leadership

Regulatory compliance

Risk assessment

Cross-functional collaboration

Education

PhD with 8+ years of relevant experience

Master’s degree with 10+ years of relevant experience

Bachelor’s degree with 12+ years of relevant experience

Associate’s degree with 14+ years of relevant experience

High School Degree with 16+ years of relevant experience

Job description

## Director, Facilities & Equipment Quality Strategy, and Technical Oversight SupportApply: Onsite Required: United States - California - Santa Monica: United States - California - Thousand Oaks: United States - California - El Segundo: Full time: Posted Today: R0055357We’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 DescriptionThe Director, Facilities and Equipment Quality Strategy and Technical Oversight, provides global Quality leadership for GMP facilities, utilities, and equipment across the company network. In 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 8+ years of relevant experience in facilities management, engineering, quality assurance, or a related field within a regulated environment OR* Master’s degree with 10+ years of relevant experience in facilities management, engineering, quality assurance, or a related field within a regulated environment OR* Bachelor’s degree with 12+ years of relevant experience in facilities management, engineering, quality assurance, or a related field within a regulated environment OR* Associate’s degree with 14+ years 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: $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\\*.