QA Specialist III Deviation and Front-Line Support

Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were 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

Knowledge

• Strong working knowledge of Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).

• Thorough understanding of FDA and EMA regulatory requirements quality systems and their interfaces with Manufacturing QC Distribution and Maintenance.

• Proficient in QA principles industry practices and quality system standards.

• Demonstrated knowledge of root cause analysis CAPA methodologies and Lean / Six Sigma tools.

• Solid experience in deviation management investigations audits and inspection readiness.

• Strong technical writing reporting and documentation review skills.

• Effective verbal communication interpersonal and stakeholdermanagement skills.

• Proficient in Microsoft Office applications.

• This role is based full time on site at Hoofddoorp including a weekend shift pattern (not hybrid or remote)

Responsibilities

• Perform a broad range of Quality Assurance activities to ensure compliance with regulatory requirements and company procedures.

• Act as a mentor and technical resource for junior QA staff.

• Maintain and continuously improve QA programs and processes to ensure product quality and GMP/GLP compliance.

• Contribute to Quality on the Floor activities including GEMBA walks and realtime QA support.

• Serve as lead or coordinator for complex deviations investigations and CAPAs including QA review and approval.

• Identify deviations from approved procedures perform impact assessments and develop solutions to complex quality issues.

• Provide frontline QA support to escalations ensuring timely actions and clear resolution paths.

• Lead or contribute to crossfunctional and QAled projects.

• Review manufacturing environmental monitoring and quality control data for inprocess and finished products.

• Write review and implement changes to controlled documents (e.g. SOPs specifications methods).

• Support and participate in regulatory inspections and external audits acting as an SME for QA processes and ensuring implementation of agreed corrective actions.

• Interface with external stakeholders and contract manufacturers to resolve documentation and compliance matters.

• Participate in annual product reviews and support new product introductions as applicable.

• Exercise sound judgment within established procedures with minimal supervision.

• Perform additional duties as assigned; responsibilities may be delegated to qualified deputies as required.

Requirements

• Bachelors degree (BS/BA) with 6 years of relevant experience in a GMPregulated environment
  or Masters degree (MS) with 4 years of relevant experience.

• Prior experience in the pharmaceutical or biopharmaceutical industry preferred.

• Demonstrated ability to work independently on routine activities and with general direction on new or complex assignments.

• Proven capability to manage complex quality issues requiring indepth analysis and riskbased decisionmaking.

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 systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at 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 individuals 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 apply via the Internal Career Opportunities portal in Workday.