Director, Facilities & Equipment Quality Strategy, and Technical Oversight Support
$191.25k - $247.5kOncology Voice Network LLC
- # Job DescriptionWe’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 The 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\\*. 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 system's 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 For 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 disability, genetic 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 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 View email address on click.appcast.io for assistance. For more information about equal employment opportunity protections, please view the 'Know 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. For Current Kite Pharma Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.## Benefits* Health insurance* Paid time off* Dental insurance
- J-18808-Ljbffr Oncology Voice Network LLC
Vacancy posted 2 days ago
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