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 Quality organization at HTO comprises Quality Assurance, Quality Systems & Compliance, Quality Control, and Quality Engineering & Validation. Together, we produce millions of units of life-saving medicine every year to patients around the world.

• You will provide quality oversight for all cGMP operations, ensuring products meet quality standards and regulatory requirements (including shop floor oversight, batch production record review, investigations for non-conformances, document approvals, batch release).
• You will create an environment with strong team spirit, timely and effective communication, sense of urgency and high motivation, and inspire teams to achieve short-term and long-term goals.
• You will support product launches through all stages of Regulatory relevant activities, including successfully managing inspections.
• As a member of the Quality Site Leadership Team, you will drive site strategy realization, networking activities, coordination, cross-functional planning and decision making.
• You will take proactive measures to promote a positive safety culture and ensure all applicable safety, health and environmental requirements are met in accordance with company policies and local legal requirements.
• You will embody Pharma Technical (PT) Lean principles and methodologies and promote a continuous improvement culture throughout the organization by encouraging experimentation and learning.
• You will optimize and protect our Quality operating model, and continually adapt to both current and future needs of the organization (skills, capabilities, technologies, staffing, etc.).
• You will partner with Manufacturing, Manufacturing Sciences and Technology, and Engineering Quality to create an environment conducive for efficient manufacturing execution and continuous improvement.
• You will help establish HTO as a center of excellence for Drug Product Manufacturing including all unit operations such as drug substance thawing, filtration, filling, lyophilization and crimping for vial and prefilled syringe products