QA Team Lead

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

We are seeking a highly motivated individual to join us as a Quality Assurance Team Lead. In this role you will support the activities of the Quality Assurance department at Kite’s Frederick, MD manufacturing site. The Quality Assurance Team Lead will ensure compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and Kite quality objectives.

***Shift is Sun-Wed 5:00 pm- 3:30 am***

Responsibilities (included but not limited to):

• Works with the Manufacturing, Quality Control, Materials Management, and Facilities/Engineering departments as a Quality Assurance representative.

• Provides oversight of the shift of QA specialists responsible for supporting operations at the site.

• Performs apheresis accession of patient material and escalate any nonconformances to the appropriate global teams.

• Performs shipment authorization of final product.

• Performs the inspection of final product labels to be released for GMP use.

• Coordinate and facilitate Quality Assurance (QA) production related activities, including:

• • Review of electronic batch records and manufacturing labels.

• • On-the-floor quality support to manufacturing and QC staff including real-time review of process comments.

• • Assessment and closure of laboratory investigations.

• • Timely assessment and closure of batch and material hold events. Review of batch manufacturing and testing documentation for timely delivery of final product.

• Ensures that tests are performed and products are manufactured in compliance with Kite specifications and regulatory and GMP guidelines.

• Supports development of SOPs and reviews/approves SOPs to ensure quality objectives are met.

• Reviews and approves test methods, manufacturing/quality control qualification/validation protocols, and reports.

• Provides QA support resolving material, in-process product, final product, environmental, facility, and equipment manufacturing issues.

• Provides QA oversight for site and network projects.

• Provides periodic updates to management for deviations, GMP and system issues, non-conforming materials and products and CAPA.

• Additional duties as assigned.

• These duties can be delegated to designated deputies of a satisfactory qualification level as needed.

Basic Qualifications:

• MA/MS in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 3+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) OR OR

• BA/BS in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 5+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) OR

• Associates in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 7+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) OR

• High School diploma and 9+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product).

Preferred Qualifications:

• Thorough knowledge of GMP, SOPs and Quality Systems

• Working knowledge and abi