THE POSITION

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 is divided into 2 production streams, which combine to produce millions of units of life-saving medicine every year to patients around the world.

• You will act as key quality contact to manufacturing for discrepancy management, line support and batch review for commercial and launch products.
• You will provide quality oversight related to operational activities, procedures and processes. You will ensure that investigations are accurate, include appropriate corrective actions, and follow regulations, industry guidelines and company standards.
• You will apply your in-depth practical and conceptual knowledge in the manufacturing and quality functional areas at the site and within the company network.
• You will support internal cGMP audits and Health Authority inspections as a technical resource and quality subject matter expert.
• You will develop new approaches to complex problems. You will lead coordination and issue resolution across HTO Manufacturing Operations, support groups and/or projects (e.g. Operations Teams) as needed.
• You will be responsible for setting the strategic direction and framework of one or multiple programs within HTO Quality in the areas of process development, process improvement, quality and compliance. You will own the deliverables within the established programs and lead teams in their execution in line with the site strategy.
• You will be accountable for managing key operational support activities related to product transfers and new equipment/process start-up (manufacturing readiness and process design, documents, engineering runs, equipment set up, etc.)