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Complaint Corporate Process Owner (GMP)

Life Sciences
QA
Master
Expert (10+)
Location
Braine-l'Alleud, Walloon Brabant
Work type
Consultancy
Work model
Fulltime, Hybrid

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.

Responsibilities

  • 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.

Requirements

  • 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.

Offer

  • Enjoy a competitive salary package with extra perks that recognize your talent.
  • Advance your career with a clear growth path, coaching, and mentoring to support you.
  • Thrive in a dynamic and supportive environment where you can truly make an impact.
  • Work when and where you perform best, ensuring an optimal work-life balance.
  • Choose a flexible transport solution, from a company car to a public transport subscription.
  • Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
  • Grow your skills with external courses and our in-house Pauwels Academy.
  • Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
  • Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.
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