Senior Manager, Quality Assurance

For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Kite we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
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.
• 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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The salary range for this position is: $126,480.00 - $163,680.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
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For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.