Sr Manager, Quality Assurance (Quality Records)United States - Maryland - FrederickQualityRegular
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.
- 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.
- 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
- 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!