QA Specialist II — GMP/GLP, CAPA & Deviation Expert

Gilead-Sciences

Hoofddorp

On-site

EUR 60,000 - 90,000

Full time

14 days+
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Job summary

Kite Pharma in Hoofddorp is seeking a QA professional to perform a variety of GMP/GLP QA activities. You will provide front‑line QA support, review deviations and CAPAs, and coordinate investigations to ensure compliance and product quality.

The role requires strong technical writing and stakeholder management, with collaboration across cross‑functional teams in a fast-paced environment.

Qualifications

  • Bachelor’s degree with 3+ years in GMP-regulated environment or Master’s with 1+ year.
  • Experience in deviation, CAPA management, impact assessments and root cause investigations.
  • Strong technical writing, reporting and documentation review skills.
  • Effective verbal communication, interpersonal and stakeholder management.

Responsibilities

  • Performs QA activities to ensure GMP/GLP compliance across processes.
  • Provides front-line QA support to escalations with timely resolution.
  • Contributes to on-floor QA and real-time support during production.
  • Reviews deviations and CAPA documents for accuracy and closure.
  • Conducts or coordinates investigations and CAPA recommendations.
  • Identifies deviations and reports to senior staff; assists in SOP development.
  • Ensures inspections and audits are conducted as specified; mentors junior staff.
  • Collaborates with cross-functional teams on QA projects.

Skills

GMP knowledge
GLP knowledge
CAPA management
Root cause investigations
Technical writing
Verbal communication
Stakeholder management
MS Office

Education

Bachelor’s degree (BS/BA) in a relevant field
Master’s degree (MS) in a related field

Tools

Microsoft Office

Job description

Kite Pharma in Hoofddorp is seeking a QA professional to perform a variety of GMP/GLP QA activities. You will provide front‑line QA support, review deviations and CAPAs, and coordinate investigations to ensure compliance and product quality.

The role requires strong technical writing and stakeholder management, with collaboration across cross‑functional teams in a fast-paced environment.

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