Senior QC Systems Specialist

QC Systems Specialist I Amsterdam | QC Systems Specialist | GMP

As Senior Specialist I - Quality Systems, you will support the deployment, governance, maintenance, and continuous improvement of Kite Pharma's Quality Management System. Acting as a compliance partner across multiple departments and stakeholders, you will ensure site quality systems remain compliant with GMP regulations, regulatory requirements, and Kite quality standards.

Key Responsibilities

• Manage and maintain Quality Systems including Change Control, Deviation, CAPA, and Material Review Board (MRB) processes.
• Deliver Quality Systems training and support user adoption across the site.
• Act as backup chair for the Change Control Review Board, Deviation Board, and Material Review Board.
• Monitor site compliance through metrics, governance activities, and management reporting.
• Review and approve changes, deviations, CAPAs, and quality system documentation.
• Support regulatory inspections, internal audits, and quality system assessments.
• Ensure proper maintenance of cGMP documentation and Quality Management System records.
• Identify and mitigate quality risks in accordance with regulatory guidelines and company procedures.
• Lead or support cross-functional quality initiatives and site start-up activities.
• Drive continuous improvement projects within Quality Systems processes.
• Support automated reporting tools and workflows when required.
• Provide day-to-day guidance to team members and act as backup to the Senior Manager Quality Systems.

What you’ll need to succeed
The successful candidate will hold a degree in Life Sciences, Bio‑Engineering, or a related field, with a background in GMP‑regulated QC laboratory work. Key requirements include:

• Strong knowledge of GMPs, pharmaceutical Law and legislation
• Experience with Change Control, CAPA, Internal Audit, Deviations, MRB and other ICHQ10 quality systems
• Strong knowledge of aseptic manufacturing processes
• Proficiency in MS Word, Excel, PowerPoint, Smartsheet, Power BI and Power Automate and Quality management systems.

Education

• Bachelor’s degree in a technical discipline (Chemistry/Microbiology/Engineering or similar)
• Knowledge/Experience
• Required: Minimum of 5 years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product).
• Working knowledge of quality systems and regulatory requirements (EU GMPs and ICHQ10)
• Preferred: ASQ, Black Belt/Green Belt certifications.
  Experience with ATMPs

Personal skills

• Strong written and verbal communication skills
• The role of a senior is very diverse and requires a flexible and pragmatic attitude and a team player.
• Ability to communicate and work independently with scientific/technical personnel
• As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together.

What you’ll get in return Hays Detachering | This is a project that will start with a contract for 6 months through Hays. In this position, you will get a competitive salary €89820 including holiday pay based on a full year, 25 days holidays and your travel expenses are covered.

Your new company
Our client is dedicated to achieving one of the most ambitious goals of 21st‑century medicine: curing cancer. This mission is at the heart of everything they do, from early research to product development. They have been at the forefront of cancer immunotherapy and today are a leader in engineered T‑cell therapy, changing the paradigm of cancer treatment with what is potentially the biggest breakthrough since the introduction of combination chemotherapy more than 60 years ago. With an unrelenting drive and a singular focus on cell therapy, their team is executing on a strategy to bring life‑saving therapies to patients.
With their brand‑new production site in Hoofddorp, they are dreaming big. Now you can get the chance to be a part of this journey.

What you need to do now
If you are interested in this role as QC Systems Specialist, click ‘Apply now’ to send an up-to-date CV, or give us a call! Is this job isn’t quite right for you, but are you still looking for a new position? Please contact us for a confidential discussion on your career.#1050564