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Sr Manager, Quality Assurance (Quality Records)

United States - Maryland - FrederickQualityRegular

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.

We are looking for a Sr Manager, Quality Assurance Specialist to join our Quality team at our new state-of-the-art Frederick, MD facility.

Responsibilities:

  • Manage a group of QA Staff that provide QA oversight and approval of deviation, OOS, and change control records.  Ensure records are properly initiated, investigated and resolved in accordance with established timelines.
  • Provide QA oversight and approval of deviation, OOS, and change control records.  Ensure records are properly initiated, investigated and resolved in accordance with established timelines.
  • Manage a group of QA Staff that provide QA oversight and approval of CAPA and EV records.  Ensure CAPAs are initiated and resolved in a timely manner.
  • Provide QA oversight and approval of CAPA and EV records.  Ensure CAPAs are initiated and resolved in a timely manner.
  • Ensure escalation of deviations per procedures
  • Direct projects that have identified efficiencies in the execution of the Deviation and CAPA processes at TCF05 in a compliant manner
  • Ensure the creation and maintenance of department metrics to ensure continuous improvement and performance
  • Provide QA support resolving in-process product, final product, manufacturing, environmental, facility and equipment and material issues.
  • Provide project management support to ensure timely closure of Quality records
  • Additional duties as assigned.
  • These duties can be delegated to designated deputies of a satisfactory qualification level as needed.

Basic Qualifications:

  • Master’s Degree and 6+ years’ experience in GMP environment and OR
  • Bachelor’s Degree and 8+ years’ experience in GMP environment and OR
  • High School Degree and 12+ years’ experience in GMP environment

Preferred Qualifications:

  • Proficient in GMPs
  • 2+ years of leadership/leading a team
  • Proficient in application of QA principles, concepts, industry practices, and standards. 
  • Has proven analytical and conceptual skills.
  • Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes
  • Demonstrates excellent verbal communication, technical writing and interpersonal skills.
  • Demonstrates working knowledge and good proficiency in Microsoft Office applications.
  • Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial.
  • Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control
  • Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial.

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