Complaint Corporate Process Owner (GMP)

Pauwels Consulting; Eigenbrakel; On-site; EUR 110,000 - 150,000; Full time

Job summary

Pauwels Consulting is seeking a Complaint Corporate Process Owner to lead and optimize global GMP complaint management across the enterprise. You will drive compliance with international regulations, oversee the central complaint unit, and champion process governance with KPI-driven reporting.

The role requires 8+ years in leadership of large-scale quality processes, deep GMP/Drug Substance-Drug Product expertise, and strong Excel data analysis capabilities, with fluency in English and

Qualifications

• 8+ years of leadership experience in quality processes.
• Expert knowledge of GMP quality principles and manufacturing in Drug Substance or Drug Product.
• Experience in risk management, including CAPAs, deviations, and audit observations.
• Strong data analysis ability in Excel to draw strategic conclusions.
• Fluent in English.

Responsibilities

• Lead the global GMP Complaint Management process, overseeing procedural requirements and documentation.
• Manage the outsourced central complaint unit, ensuring adherence to quality and training standards.
• Establish governance models for continuous process improvement with KPIs and performance reporting.
• Act as the primary eQMS super user for complaint flows, providing technical support and enhancements feedback.
• Maintain inspection readiness for procedural documents and participate in quality audits.
• Analyze product complaint data and generate trending reports for senior leadership.
• Collaborate with global stakeholders to align and promote best practices across sites and affiliates.

Skills

Leadership experience

GMP knowledge

Risk management

Excel proficiency

Stakeholder influence

English fluency

Tools

Excel

Job description

Our client, a leading biopharmaceutical organization, is seeking a Complaint Corporate Process Owner to manage and optimize global complaint management systems. This role ensures process compliance with international regulations while driving operational excellence through cross-functional collaboration and strategic oversight.

• Lead the global GMP Complaint Management process, overseeing procedural requirements and associated documentation.
• Manage the performance of the outsourced central complaint unit, ensuring adherence to quality and training standards.
• Establish governance models for continuous process improvement and monitoring through key indicators and performance reporting.
• Act as the primary eQMS super user for complaint flows, providing technical support and system enhancement feedback.
• Maintain inspection readiness for procedural documents and participate in internal and external quality audits.
• Analyze product complaint data and generate trending reports for presentation to senior leadership.
• Collaborate with global stakeholders to ensure alignment and promote best practices across manufacturing sites and affiliates.

• You possess 8+ years of leadership experience, including the management of teams and large-scale quality processes.
• You bring expert knowledge of GMP quality principles and manufacturing expertise in Drug Substance or Drug Product.
• You're experienced in risk management, including the oversight of CAPAs, deviations, and audit observations.
• You have a strong process improvement mindset with the ability to analyze complex data in Excel to draw strategic conclusions.
• You possess excellent interpersonal skills and the ability to influence senior internal and external stakeholders.
• You are fluent in English.

Nice to Haves

• Experience with Combination Product and Device QMS regulatory requirements.
• Knowledge of French.