Senior Manager, Quality Assurance

Job Description

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a 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.
• 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
• Oversee projects that have identified efficiencies in the implementation 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.

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 demonstrated 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!

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