QA Specialist III Deviation and Front-Line Support

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

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 stakeholder‑management 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 real‑time 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 front‑line QA support to escalations, ensuring timely actions and clear resolution paths.

• Lead or contribute to cross‑functional and QA‑led projects.

• Review manufacturing, environmental monitoring, and quality control data for in‑process 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

• Bachelor’s degree (BS/BA) with 6+ years of relevant experience in a GMP‑regulated environment, or Master’s 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 in‑depth analysis and risk‑based decision‑making.

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.