About this role
Manager, Global Quality Intelligence & Product Quality Complaints
About the Role
As a Manager in Global Quality Intelligence & Product Quality Complaints, you will be responsible for establishing, implementing, and continuously improving a comprehensive Global Quality Assurance oversight framework to ensure robust GMP compliance for Marketing Authorization Holder (MAH) and Sponsor related activities across the global pharmaceutical footprint. You will drive the oversight, execution, and continuous improvement of the end-to-end complaint handling process for both clinical trial materials and commercial pharmaceutical products, and serves as a critical interface between Quality Assurance, Manufacturing, Supply Chain, Regulatory Affairs, Pharmacovigilance, Clinical and Commercial Operations, and external partners to ensure patient safety, product quality, and regulatory compliance.
Your Contribution
- Ensure regional and global compliance in the capacity of an MAH/Sponsor representative by addressing evolving global regulatory expectations.
- Contribute to the development and maintenance of procedures, training, and quality oversight processes supporting product lifecycle, regulatory surveillance, recalls, and related MAH/Sponsor responsibilities.
- Build and maintain processes (e.g. Product Specification Files (PSFs)) ensuring compliance with product‑relevant regulatory documentation (BLAs, MAAs, IMPDs, etc).
- Manage the end-to-end lifecycle of Product Quality Complaints (PQC) for clinical trial materials and commercial pharmaceutical products, ensuring effective intake, triage, assessment, investigation, classification, disposition, and closure.
- Ensure compliance with global regulatory requirements, internal procedures, and reporting obligations related to complaint handling.
- Lead complaint investigations and CAPAs, oversee third-party activities, and drive the timely escalation of quality and compliance risks.
- Serve as the primary point of contact for PQC-related activities, fostering effective collaboration across Quality, Pharmacovigilance, Medical Information, Release Hub, Supply Chain, and external partners.
- Support and represent the organization during inspections and audits related to MAH/Sponsor oversight and complaint handling, providing experti