Quality Assurance Director - Urbana, MD

Employer
Kite Pharma
Location
Frederick, MD, United States
Posted
Aug 12, 2019
Ref
R0008473
Required Education
Doctorate/PHD/MD
Position Type
Full time
We are seeking a highly motivate individual for the role of Director, Quality Assurance to work in this exciting new area of cancer immunotherapy. This position will report into the Executive Director Quality, Quality Site Head. The role will be based at our new commercial site in Urbana, MD.

In this position, you will lead the GMP commercial and clinical operations at the site and be a member of the site quality leadership team, guiding site quality strategy and delivery. You will also utilize quality tools such as lean, six sigma, risk management and other risk based tools to continually improve operations.

Responsibilities and management include (but not limited to):
  • Functional leadership including managing a large technical staff.
  • Perform and oversee the lot disposition process
  • Knowledgeable about electronic Quality Systems
  • Approve Deviations and CAPAs
  • Provide support for audits and regulatory inspections
  • Approve master batch records, procedures and protocols.
  • Perform change control assessments Quality Systems including document management, change control, CAPA.
  • 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 process development, manufacturing, supply chain, commercial, translational sciences, engineering, corporate, other sites and clinical groups
  • Assures site quality training system is effective
  • Develop procedures and processes for efficient oversight and release of GMP consumables, disposables, raw materials, final product
  • Develop process and procedures for Quality on the floor activities
  • In collaboration with the Quality Systems team, ensure all deviations/change controls from established procedures are appropriately documented and investigated to determine and address root cause
  • Other duties as assigned


Qualifications:
  • Minimum experience of 10 years in a technical role in quality assurance, manufacturing, QC or quality engineering with demonstrated manufacturing plant experience
  • 5+ years of people management experience.
  • Bachelor's degree in Engineering, Chemistry or biological sciences required. Advanced degree preferred. ASQ Auditor certification, ASQ Quality Engineer certification preferred
  • Experience in medical device or pharmaceutical bio-pharmaceutical field required.
  • Education or training in cell culture and gene therapy a plus.
  • Extensive working knowledge of quality system requirements such as US FDA GMP, GCP, EMA, and ICH guidelines and has 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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