Senior Quality Engineer

For Current Kite Pharma Employees and Contractors:

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

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

Job Description

As a Senior Quality Engineer, you’ll be joining a team in which people of diverse backgrounds and experiences are respected and are working together focused on saving lives by finding the cure for cancer. You will report to the Senior Manager of Quality Engineering of the manufacturing plant in Hoofddorp (TCF04).

Your profile

• Provide quality oversight for network and local computer systems validation, enterprise systems and IT infrastructure, in providing approach, methodology and deliverables in compliance with GMP regulations, 21 CFR Part 11, EU Annex 11 and Data Integrity guidelines.
• Identify industry trends and look for opportunities to leverage best practices to improve future state processes. (e.g. CSA, Paperless lab, AI)
• Drives use of best-practices during IT infrastructure design, validation, and use based on Kite Policies and procedures, cGMP, data integrity and risk based practices.
• Collaborate with IT, OAT, QC and other site departments to maintain and support electronic systems that are compliant, efficient, effective and reliable.
• Provide Quality input, oversight and approvals for validation documents to ensure Quality, Data integrity and compliance to Kite procedures.
• Supports the review and approval of quality system management records (Change Controls, Deviations, CAPAs) as required.
• Ensures the application of data integrity regulations and guidelines from governing agencies when participating in site and global projects related to computerized systems.
• Support risk-based approach to qualification of computerized systems.
• Quality oversight of validation documents (Validation plan, SIA,URS, IOQ , Traceability Matrix etc.) with functional teams, ensuring the documentation meets compliance requirements and quality standards.
• Drive continuous process improvement in the area of computer system validation, enterprise systems, IT infrastructure and data integrity
• Support the team when needed in CQV quality oversight activities and Quality Risk Management oversight activities for the site (in house training will be provided)

Your new role

• BSc degree in Science, Engineering, Computer Science to relevant scientific field.
• Previous experience in FDA/EU regulated environment with good understanding of GxP standards, IT infrastructure compliance, Risk based validation and cGMP manufacturing for biotech/pharmaceuticals.
• Knowledge of EU and FDA guidance’s, regulatory regulations and industry standards on computerized systems in pharmaceutical industry
  (i.e., Quality Systems, GAMP5, 21CFRPart11 and EudraLex Volume 4 Annex 11).
• Experience with the creation, review, and execution of qualification protocols (IQ/OQ/PQ) and associated validation lifecycle documentation, including identification and resolution of exceptions/deviations.
• Strong knowledge of GAMP and Data Integrity industry requirements and how they apply to IT.
• Experience in CQV and Quality Risk Management is a plus

Your soft skills

• Ability to think critically and utilize troubleshooting and problem-solving skills.
• Self-motivated and willing to accept temporary responsibilities outside of initial job description.
• Excellent interpersonal, verbal and written communication skills and ability to work in collaborative and fast paced work environment.
• Has demonstrated the following leadership behaviors: Ethics & Integrity, Focus on Customers, Drive Results, Build Talent, Collaborate.
• Excellent interpersonal and communication skills.
• Strategic thinking.

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 .

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company.  Except if otherwise provided by applicable law, all  employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws).  Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Kite Pharma Employees and Contractors:

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