Quality Specialist

Quality Specialist

Start: ASAP
Duration: 6 months (possible extension)
Location: Leiden, Netherlands (Hybrid)
Hours: Full-time
Sector: Biopharmaceuticals / Pharmaceutical Manufacturing / Quality Assurance / Quality Control / GMP Compliance

About the Role

A leading global biopharmaceutical organization is seeking an experienced Quality Specialist to support its Quality Control organization. In this role, you will lead quality investigations, perform root cause analyses, coordinate corrective and preventive actions, and support compliance with GMP and regulatory requirements. Working closely with Quality, Manufacturing, Supply Chain, and Regulatory Affairs teams, you will play a key role in maintaining product quality and driving continuous improvement.

Key Responsibilities

• Lead and manage quality investigations and non-conformance records.
• Perform root cause analyses and implement corrective and preventive actions (CAPAs).
• Assess quality events for potential product quality and compliance impact.
• Ensure timely and accurate documentation of investigations and quality records.
• Collaborate with cross-functional stakeholders to resolve quality issues.
• Support internal audits, inspections, and quality assessments.
• Monitor quality trends and identify opportunities for process improvement.
• Drive continuous improvement initiatives across quality systems and processes.
• Contribute to training and coaching activities related to investigations and GMP compliance.

Who We're Looking For

You are an experienced quality professional with a background in pharmaceutical manufacturing, quality operations, or laboratory environments. You are comfortable managing investigations, working with multiple stakeholders, and driving sustainable improvements in a highly regulated GMP environment.

Must-Haves

• Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Biotechnology, or a related scientific discipline.
• 3-5+ years of experience in Quality Assurance, Quality Control, Compliance, or a related pharmaceutical environment.
• Experience with investigations, deviations, non-conformances, and CAPA management.
• Strong understanding of GMP requirements and pharmaceutical quality systems.
• Experience with Quality Management Systems (QMS).
• Strong analytical, problem-solving, and stakeholder management skills.
• Excellent communication skills in English.

Preferred

• Experience within biologics, vaccines, advanced therapies, or other highly regulated manufacturing environments.
• Experience supporting regulatory inspections and audits.
• Familiarity with FDA, EMA, ICH, and cGMP requirements.
• Experience in QC laboratories, manufacturing operations, or quality systems environments.
• Knowledge of Lean, Six Sigma, or other continuous improvement methodologies.

Let op: vacaturefraude

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* Wij zullen nooit via WhatsApp of in een videogesprek vragen om jouw persoonlijke gegevens (zoals een kopie van je ID, bankgegevens of BSN).
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Important: job fraud

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* We will never ask for personal information (such as a copy of your ID, bank details, or social security number) via WhatsApp or during a video call.
* If you're unsure whether a vacancy or contact person is legitimate, please reach out to us directly using the official contact details on our website.