Quality Assurance Manager

A privately owned, mid-sized international pharmaceutical company with a strong European footprint is seeking an experienced QA Manager / Responsible Person to support its Benelux operations. The company specializes in the development and commercialization of niche hospital and orphan medicines addressing unmet medical needs across several therapeutic areas.

This organization operates with a strong values-driven culture, emphasizing integrity, reliability, ambition, and agility.

Role Overview

The QA Manager / Responsible Person is accountable for maintaining and developing the local quality system and ensuring compliance with applicable GMP, GDP, EU, and national (Netherlands/Belgium) regulatory requirements, as well as corporate quality standards.

This role acts as a key quality authority within the Benelux organization and works closely with corporate quality teams and the local Qualified Person (QP).

Key Responsibilities

• Maintain and continuously improve an effective GMP/GDP-compliant quality management system
• Monitor and oversee all quality-impacting operations across the local product portfolio
• Act as Responsible Person in line with EU regulatory requirements
• Ensure products comply with Marketing Authorisation requirements
• Implement KPIs to measure quality system performance and effectiveness
• Drive quality awareness through training, visibility, and stakeholder engagement
• Manage deviations, OOS, complaints, change controls, CAPAs, and trend analyses
• Oversee Product Quality Reviews (PQRs) and stability programs
• Qualify, audit, and manage suppliers and service providers, including technical agreements
• Host and participate in regulatory inspections and external audits
• Maintain licenses and authorizations and ensure ongoing inspection readiness
• Execute and manage the internal audit program
• Provide technical QA support to contract and partner-related activities
• Collaborate closely with corporate quality functions and support QP activities as required

Qualifications & Experience

Education

• Scientific degree (Bachelor or Master) or Pharmacist with a QA specialization

Experience

• Minimum 3 years’ experience in QA, QC, or production within pharmaceuticals, medical devices, or food industries
• Lead auditor experience (internal and/or external)
• Strong understanding of batch release and Quality Control processes
• Solid knowledge of GMP, GDP, and relevant EU and national legislation

Key Skills & Competencies

• Excellent written and verbal communication skills
• Fluent in Dutch and English
• Strong organizational and time management abilities
• Able to work independently with a collaborative mindset
• Proactive problem-solver with strong critical-thinking skills
• High attention to detail and accuracy
• Strong ethical judgment and integrity
• Ability to create structure, processes, and sustainable quality frameworks

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.