QA Team Lead

Employer
Kite Pharma
Location
El Segundo, CA, United States
Posted
Aug 21, 2020
Ref
R0014855
Required Education
Bachelors Degree
Position Type
Full time
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

We are seeking a highly motivated individual to join us as a Quality Assurance Specialist III at the commercial manufacturing site in El Segundo. You will report into the Associate Director, QA Operations. This position will have 6-8 direct reports. In this role, you will ensure quality product and timely delivery - every patient, every time.

Responsibilities (included but not limited to):

• Oversee and perform receipt and disposition of incoming apheresis material.

• Oversee and authorize shipment of final product.

• Oversee and perform verification and ensure timely issuance of final product labels.

• Oversee and review batch-related documentation, and ensure resolution of issues to release and ship product.

• Oversee and perform incoming label inspection.

• Create/issue daily schedule and schedule staff to execute daily tasks in order to ensure on-time delivery of product to patients.

• Lead and coordinate staff training and qualification activities.

• Maintain huddle board, gather and report metrics to measure performance.

• Identify compliance risks and escalate the issues to management for resolution

• Support optimization of organizational structure to adapt to the fast growing needs of the business.

• Support/Lead department projects and identify risks to internal and external processes associated with projects; ensures alignment and harmonization across regions for global changes and projects.

• Ensure all product-related deviations are initiated, investigated, resolved and closed in a timely manner.

• Provides for the training and development of direct reports.

• Develops and executes Quality objectives in alignment with department goals and process improvement initiatives.

• Participate on teams developing global policies and procedures, as needed.

• Assigns, monitors and reviews progress and accuracy of work of direct reports.

• Own change control, deviation and CAPA quality system records on behalf of QA Ops Accession team.

• Participates in the development, implementation and maintenance to optimize department procedures; writes and implements controlled documents. Update/Initiate/Author/Approve procedures and forms in GVault as assigned.

• Provide oversight and support to ensure compliance to GMP throughout assigned area.

• Provide Quality Assurance support resolving material, receiving/shipping, in-process product, final product, or manufacturing issues.

• Ensure products are manufactured in compliance with regulatory and GMP guidelines.

• Support inspection readiness plans and provide support during compliance audits and regulatory inspections.

• Perform other duties as required to fulfill department and business needs.

Requirements:

• Bachelor's degree in the biological sciences or related field and minimum of 5-6 years progressive experience in a pharmaceutical, biotechnology, or biologics operation, or equivalent education/work experience.

• Demonstrates strong technical writing, critical thinking and problem-solving skills.

• Experience with quality management systems, and system development, validation and implementation.

• Experience with investigations, deviations, CAPA, change control and validation principles

• Experience with internal and external audits.

• General knowledge of aseptic manufacturing processes

• Working knowledge and ability to apply FDA, EMEA and ROW standards and quality systems, and the interface with other functions like manufacturing, supply chain and patient program operations.

• Leads by example to foster a commitment to quality in personnel, and a culture of quality within the organization.

• Ability to effectively negotiate and build collaboration amongst individuals.

• Good interpersonal, verbal and written communication skills.

• Ability to communicate and work independently with other departments.

• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities

• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.

• Proficient in MS Word, Excel, Power Point and other applications

• Available to work on weekends (Saturday or Sunday), certain holidays and/or swing shift schedule

Preferred Qualifications:

• Experience in both clinical and commercial manufacturing environment.

• Team lead or supervisory experience.

• Experience with Cellular & Gene Therapy Products, blood and blood product or biologics.

• Experience presenting and responding to regulatory agency audits.

• Experience with MES/Electronic Batch Record, Oracle, LMS, GVault.

• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.

#IND123

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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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.