Executive Director, Head of Quality Systems and Quality Processes

职位描述

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?

We are seeking a highly motivated individual for the role of Executive Director, Head of Quality Systems and Quality Processes reporting to the Global Head of Quality and responsible for developing the Quality systems and processes function globally. In this role, as a key member of the Global Quality Leadership Team, you will collaborate cross-functionally with Regulatory Affairs, Legal, Manufacturing, Process Development, Supply Chain, Facilities & Engineering, CMC Regulatory, Business Operations, IT, HR and Finance to ensure the results of quality systems and quality processes supporting Kite Technical Operations.

The Executive Director, Head of Quality Systems and Processes is responsible for oversight of Kite global quality risks and reporting risks through the risk register to senior stakeholders. Cell therapy is a new and emerging therapeutic area and requires critical thinking in the effective and efficient development of quality teams as well as quality systems and processes. Primary scope is to ensure effective and compliant Kite Quality Systems and Quality Processes including maintenance of the core Kite Quality Management System; Training, Deviation, CAPA, Change Control, Documentation, Quality Management Review, and Audit & Inspection Management. Additionally, providing direction into the operational design, implementation and effectiveness systems, processes and team supporting data collection/storage/transmission, data analytics and governance, AI/machine learning controls, and data compliance including data integrity.

Responsibilities include but are not limited to:

• Strategy – Partner with stakeholders and functional team guides to develop a comprehensive quality systems program fit for cell therapy. Implement the program in a systematic, efficient and effective manner.
• Compliance – Set global compliance standards based on country boards of health regulations and guidance as well as industry standards in collaboration with Gilead Quality partners.
• Quality Risk Management – Develop and manage comprehensive QRM system. Assure efficient, effective implementation of QRM resources across global network.
• Regulatory Reporting – Assure oversight of all critical quality events globally. Assure timely and technically accurate reporting of events such as BPDR, field alerts, etc. are completed.
• Quality Processes – Continue to refine our electronic systems that collect, store, and transmit data, and the establish controls and governance processes for the use of GxP data. Establish and provide direction to network quality business process owners to ensure cross site process alignment and support of company level systems and Quality Management Systems processes (Deviation, CAPA, Change Control, Documentation & Records, Training, and Management Review).
• Quality Management System – Manage global quality management system to assure its performance and compliance, including relevant meaningful control metrics and reporting of system health to Sr. Stakeholders for review.
• Audit System/ Inspection Management – Create and manage a global audit program and processes to ensure Global inspection readiness.
• Talent Development – Developing both individual contributor subject matter experienced professionals, matrixed indirect reporting teams and direct reporting teams, shape and develop an inclusive high performing team, develop the next generation of leaders by creating a feedback rich culture, ensuring effective personal development of leaders, and developing a deep succession pipeline

Basic Qualifications:

• PhD degree in life sciences, engineering or related field with 14+ years of relevant experience in the biotechnology or biologics industry OR
• Master’s degree in life sciences, engineering or related field with 14+ years of experience in the biotechnology or biologics industry OR
• Bachelor’s degree in life sciences, engineering or related field with 16+ years of experience in the biotechnology or biologics industry OR
• High School diploma and 20+ years of experience in the biotechnology or biologics industry

Preferred Qualifications:

• International Mindset – Previous regional and global responsibility, international assignment preferred. Experience developing global functions, domestic and/or international manufacturing sites.
• Interpersonal Skills – Accessible, humble, confident, bold. Ability to give and earn trust. High level of emotional intelligence, exceptional listening, verbal and written communication skills.
• Decision Making - Demonstrated ability to make impartial, inclusive, extensive and unbiased decisions with imperfect information. Ability to embrace other people’s point of view - especially if different than one’s own.
• Cross-functional Collaboration – Cross-functional, corporate and site experience with a focus on bringing diverse perspectives together, sharing best practices, and effectively leveraging resources in an inclusive manner to further Kite’s company program and achieve Technical Operation’s targets.
• Change Management - Effective Sponsorship and influencing skills. Adaptive, agile, flexible, open minded. Demonstrated ability to develop cross-functional commitment, lead, simplify and scale complex dynamic organizations through change.
• Business & Scientific Acumen - Broad understanding of the business model, science, manufacturing, facilities, engineering, process development, supply chain, regulatory, and information technology expectations for cell therapy.
• Drug Development - Understands product life cycle management from early clinical phases through commercialization, and how to translate creative clinical process and assay development into regulatory program to gain Health Authority approval and advance the pipeline.
• Enterprise Leadership - Ability to shape inclusion, empowerment and accountability across teams and functions by being bold in aspiration and agile in implementation, caring and making time for people, listening, speaking openly and explaining the “why,” trusting in others and oneself to make sound decisions, and owning the impact of one’s words and actions.
• Entrepreneurial - High energy level with a positive “can do” attitude, ability to adapt and think “out of the box” and rapidly turn ideas into action in a nascent and evolving industry. Manage ambiguity with ease and calmness. Comfortable with risk-taking.
• Travel up to 25%

Does this sound like you? If so, apply today!

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The salary range for this position is: $249,645.00 - $323,070.00. 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:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* 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 www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.