Vice President, Quality - Commercial Manufacturing

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Oct 28, 2020
Ref
R0014704
Required Education
Doctorate/PHD/MD
Position Type
Full time
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

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

Job Description

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. This role is based out of Kite Corporate Office, located in Santa Monica, CA.

The Head of Commercial Manufacturing Quality reports to the Global Head of Quality and is responsible for leading the Quality function across multiple Commercial Manufacturing Sites globally. The Head of Commercial Manufacturing Quality will collaborate cross-functionally with Manufacturing, Process Development, Supply Chain, Facilities & Engineering, CMC Regulatory, Business Operations, IT, HR and Finance to ensure the success of Kite Technical Operations.

This position will lead Quality Heads at each Commercial Manufacturing site and hold responsibility for developing quality's strategy at the commercial manufacturing sites, establishing new capabilities, and standardizing Quality process & technology across network. In addition, this position will ensure cGMP compliance while building teams and developing people to create an inclusive culture of quality excellence.

Responsibilities include, but are not limited to:
  • Strategy - Partner with Quality Leadership Team executives to establish and align on cross-functional strategies and shared global objectives. Lead Quality at Commercial Sites in the development of functional and site strategies, budgets, goals, objectives, etc. which are cross-functionally aligned.
  • Global Network - Closely partner with Facilities & Engineering, Manufacturing, IT and Finance to complete the construction, expansion and integration of Quality at 2 new commercial sites and 1 viral vector site. Partner with Business Operations to ensure global processes and systems effectively and efficiently connect and align across sites and Quality functions.
  • Quality Operations - Assure robust and consistent systems are in place at each commercial site for lot disposition.
  • Quality Systems - Assure quality systems and policies are standardized at all commercial sites.
  • Compliance - Maintain a high level of cGMP compliance and safety through the effective monitoring and reporting of key metrics.
  • Inspection Management - Provide inspection oversight including US FDA, EU EMA, and other country boards of health as required.
  • Quality Control - Assure all quality control laboratories are managed consistently and in alignment with analytical development directives.
  • Continuous Improvement - Closely partner with Business Operations and Process Development to ensure process alignment and drive product/process improvements to improve reliability, quality, productivity and efficiency. Create an open, inclusive and "speak-up" environment to ensure that the best innovative solutions are identified and implemented.
  • Talent Development - Closely collaborate with HR to build and develop an inclusive high performing leadership team, develop the next generation of leaders by creating a feedback rich culture, ensuring effective personal development of leaders, and building a strong succession pipeline.
  • Training Management - Assures training system is effectiveacross Quality at Commercial Sites


Basic Qualifications:
  • PhD in life sciences, engineering or related field with 14+ years of experience managing operational teams in the biotechnology or biologics industry OR
  • MS, MBA in life sciences, engineering or related field with 16+ years of experience managing operational teams in the biotechnology or biologics industry OR
  • BS degree in life sciences, engineering or related field with 18+ years of experience managing operational teams in the biotechnology or biologics industry


Preferred Qualifications:
  • International Mindset - Previous regional and global responsibility, international assignment preferred. Experience leading global functions, domestic and/or international manufacturing sites.
  • Interpersonal Skills - Vulnerable, humble, confident, courageous. Ability to give and earn trust. High level of emotional intelligence, exceptional listening, verbal and written communication skills.
  • Decision Making - Proven ability to make objective, inclusive, robust 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 enterprise strategy and achieve Technical Operation's objectives.
  • Change Management - Effective Sponsorship and influencing skills. Adaptive, agile, flexible, open minded. Proven ability to build 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 innovative clinical process and assay development into regulatory strategy to gain Health Authority approval and advance the pipeline.
  • Enterprise Leadership - 10+ years of senior leadership experience and the ability to build inclusion, empowerment and accountability across teams and functions by being bold in aspiration and agile in execution, 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, evolving, innovative industry. Manage ambiguity with aplomb and calmness. Creative, innovative and comfortable with risk-taking.


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.