Our client is seeking an experienced External Quality Senior Specialist to support Quality Process & Operations activities within a global pharmaceutical environment. This role focuses on strengthening External Quality processes, supplier oversight, quality systems management, regulatory compliance, and continuous improvement initiatives across external manufacturing and supplier networks.

The successful candidate will act as a key contributor to quality process optimisation, quality systems governance, and cross-functional improvement projects while ensuring compliance with GMP and global regulatory requirements.

Key Responsibilities

External Quality & Quality Systems

• Own and support External Quality (EQ) processes across the supplier lifecycle.
• Develop, review, and update External Quality procedures and quality standards.
• Manage and support Global and External Quality Management Systems (QMS).
• Ensure alignment of quality procedures with company and enterprise standards.
• Monitor effectiveness of existing quality processes and recommend improvements.
• Drive implementation of industry best practices across External Quality activities.
• Support compliance with GMP, regulatory, quality, and corporate requirements.

Supplier Quality Oversight

• Support quality oversight of CMOs, external manufacturers, and supplier partners.
• Build effective relationships with suppliers and external stakeholders.
• Contribute to supplier quality governance and risk management activities.
• Support audit readiness and supplier compliance initiatives.

Process Improvement & Compliance

• Lead and contribute to continuous improvement initiatives.
• Identify process gaps, risks, and system constraints.
• Conduct root cause investigations and support CAPA implementation.
• Ensure processes remain lean, efficient, and compliant.
• Utilize regulatory intelligence to maintain compliance with evolving requirements.

Projects & Operations

• Support strategic quality and business improvement projects.
• Participate in the implementation of new operating processes and systems.
• Collaborate with cross-functional stakeholders including Quality, Manufacturing, Regulatory Affairs, Validation, and Operations.
• Support project management activities related to External Quality processes.

Requirements

Essential

• Bachelor's degree in Science, Engineering, Pharmacy, or related discipline.
• Minimum 5 years' experience within the pharmaceutical or biotechnology industry.
• Strong knowledge of GMP/cGMP regulations and quality systems.
• Experience working with external manufacturers, CMOs, or supplier quality programs.
• Knowledge ofQMS processes, including:
  • Deviations
  • CAPAs
  • Change Controls
  • Audits
  • Risk Management
• Experience supporting quality compliance and process improvement initiatives.
• Strong analytical and problem-solving skills.
• Ability to work independently within a remote environment.
• Excellent stakeholder management and communication skills.
• Proficiency with SAP and Microsoft Office.

Preferred

• Experience across multiple quality functions such as QA, QC, Validation, Quality Systems, Regulatory Affairs, Operations, or NPI.
• Experience managing global quality processes.
• Knowledge of supplier lifecycle management and external quality governance.
• Project management experience within a GxP-regulated environment.

Key Skills

• External Quality
• Supplier Quality
• CMO Management
• GMP / cGMP
• QMS
• CAPA
• Deviations
• Change Control
• Quality Systems
• Supplier Audits
• Compliance
• Regulatory Affairs
• Risk Management
• Root Cause Analysis
• Process Improvement
• Continuous Improvement
• External Manufacturing
• Validation
• Quality Assurance
• Quality Oversight
• Project Management
• SAP

Candidate Profile

We are looking for a quality professional who combines a strong pharmaceutical quality background with experience supporting external suppliers and manufacturing partners. You should be comfortable working across quality systems, process improvement initiatives, and compliance activities while collaborating with stakeholders in a global environment.

Please note: Candidates must already possess the right to work in Belgium. This is a fully remote position, with occasional travel potentially required for business needs.