Complaint Corporate Process Owner
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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.
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