Specialist-Software Audit Quality Engineer

KITE PHARMA, INC. Santa Monica, CA
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 experienced individual to join us as a Specialist-Software Audit Quality Engineer reporting to the Corporate Quality Engineering Manager. The Software Audit Quality Engineer is responsible for the overall management and maintenance of the software vendor qualification program.

Responsibilities

* Assist in management and enhancement of supplier qualification process that will use risk-based tools for classification, qualification and monitoring.

* Perform audits for quality and cGxP compliance (desk and on-site at vendor) and manage audit closure for software service providers.

* Develop and review supplier service agreements (in collaboration with Legal and Supply Chain) and establish a process to assure key quality expectations are reflected in supplier's operations and updates for changes are managed.

* Collaborate with impacted Departments to ensure impacted computer systems and Sites are assessed and mitigation plans in place.

* Assist in the management and execution of supplier change management system for software service providers and own change control records, as necessary.

* Assist in maintaining the audit schedule, periodic reviews, and approved supplier list (Oracle Agile and EBS) for assigned suppliers.

* Maintain the software service provider qualification documentation and system of record.

* Ensure software service provider documentation, qualification status, and other associated requirements are in compliance to governing documents and regulations.

* Act as Quality contact for supplier issues and discrepancies (SCARs), and lead/manage the investigations to resolve the issues.

* Participate in selection and qualification of new suppliers.

* Review and approve computer validation documentation.

* Manage the introduction of new software service providers into impacted Sites and Departments.

* Perform metrics monitoring and refine metrics as needed.

* Maintain cGxP computerized system inventory list in compliance with SOPs.

* Support cGxP inspection readiness plans and interact with regulatory agencies during inspections on supplier quality related matters, as needed.

* Ability to travel up to 25%

* Perform other duties as assigned.

Qualifications

Bachelor's degree in biological sciences, Computer Sciences, or Materials Science with minimum of 2 years' experience in a pharmaceutical, software validation, or biologics supplier quality management role

OR

Master's degree in biological sciences, Computer Sciences, or Materials Science with minimum of 1 year of experience in a pharmaceutical, software validation, or biologics supplier quality management role

* Knowledge and experience executing or implementing GAMP requirements and a risk based approach for service provider qualification.

* Experience auditing software service suppliers.

* Experience reviewing, executing, and/or performing computerized system validation documentation preferred.

* QA Operations experience, a plus (e.g., product disposition, deviations, change control, material review board, process validation)

* ASQ Certified Quality Auditor preferred

* Experience in identifying, writing, evaluating and closing investigations and change control records.

* Working knowledge of and ability to apply GMP in conformance to US, EU and ROW standards.

* Proficient in MS Word, Excel, and Power Point

* Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.

* Comfortable in a fast-paced small company 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.

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.