Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products. The Operations organization at HTO produces millions of units of life-saving medicine every year for patients around the world. The Opportunity: In this exciting role, you will be part of a dynamic and inclusive team. You will act as lead investigator for complaints, critical deviations and the associated escalation process.You will be a mentor and coach for the organization and the network and you will provide quality oversight for our commercial production and the complaints at the Hillsboro site. You will lead complaints and critical deviations with minimal guidance and ensure investigation action plans and final investigation summaries are accurate, include appropriate corrective actions and follow company standards. You will own and/or support complaint trending activities including, but not limited to annual product quality reviews and quarterly trending reports. You will collaborate with departments (e.g. Affiliates, Manufacturing sites, external quality, quality control etc.) to establish appropriate, efficient, and timely investigation plans. You will notify senior management of potential quality or regulatory issues that may impact product quality or regulatory compliance. You will communicate new and updated regulatory requirements and evaluate systems in place. You will support internal cGMP audits and Health Authority inspections as needed, and follow up on any corrective measures. You will solve complex problems; both inside and outside of the quality organization You will work independently within standard guidelines, policies and health authority regulations and mentor others You will serve as primary consultant to senior management and internal/external spokesperson for the organization