Executive Director, Quality - Urbana, MD

Employer
Kite Pharma
Location
Frederick, MD, United States
Posted
Oct 16, 2019
Ref
R0008992
Required Education
Bachelors Degree
Position Type
Full time
We are seeking a highly motivated individual for the role of Executive Director of Quality to work in this exciting new area of cancer immunotherapy. This position will report into the Senior Vice President of Quality and Compliance and be based at our new commercial site in Frederick, MD.

This Executive Director leads the GMP Commercial Yescarta and clinical trial stage quality functions including Quality Systems, Quality Operations, QC Analytical and QC Microbiology and will sit on the Kite quality leadership team guiding company quality strategy and delivery. The Executive Director will utilize quality tools such as lean, six sigma, risk management and other risk based tools to continually improve operations.

Responsibilities and management include:
  • Site and functional leadership including managing a large technical staff.
  • Quality Operations including lot disposition, audits, and deviation management
  • Quality Systems including document management, change control, CAPA and quality policy management.
  • Quality Control analytical and microbiological and environmental monitoring laboratory management.
  • Inspection Management including US FDA, EU EMA, and other country boards of health as required.
  • Develops and implements annual quality plans, departmental goals, action plans, and budgets according to Kite Pharma, Inc.
  • Independently reports quality metrics to executive management through Management Review process
  • Responsible for talent management including recruitment, selection, development, training & retention of quality staff at the site and ensures that proper quality skill sets and competencies are consistent with business and technology plans
  • Collaborates with product sciences, manufacturing, supply chain, commercial, translational sciences, engineering and clinical groups
  • Assures site quality training system is effective
  • Establishes the site annual internal quality system audit schedule and maintains the site internal audit system
  • Approves or oversees review and approval of process and method validation, qualifications and validation reports, change control documents, and technical reports
  • Other duties as assigned


Requirements:
  • At least 15 years in a technical role in quality assurance, manufacturing, QC or quality engineering with demonstrated manufacturing plant experience with at least 10 years in a related management role
  • Bachelor's degree in Engineering, Chemistry or biological sciences required. advanced degree preferred (education or training in cell culture and gene therapy a plus), ASQ Auditor certification, ASQ Quality Engineer certification preferred
  • Experience in medical device or pharmaceutical bio-pharmaceutical field required
  • Extensive working knowledge of quality system requirements such as US FDA GMP, GCP, EMA, and ICH guidelines and have a proven track record of successfully implementing these requirements
  • Knowledge of fundamental quality engineering principles such as process validation, process capability, process control, and structured problem solving
  • Demonstrated ability to successfully interact with regulatory health authorities at inspections
  • Ability to lead and influence cross functional employees to ensure compliance
  • Ability to effectively present information in small and large group situations to staff, customers, regulators, and executive management
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Proficient in MS Word, Excel, Power Point, Visio, Project, and statistical software


IND123

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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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