Director, Drug Product Quality Assurance

 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.

The Opportunity:

In this exciting role, you will lead a dynamic and inclusive team responsible for ensuring Quality supply of  life-saving medicines for our patients. You have the unique opportunity 

to lead our Quality Assurance team and drive compliance and continuous improvement initiatives at the site and through our network. The Head of Quality Assurance is accountable for quality oversight for all cGMP operations, ensuring products meet quality standards and regulatory requirements. Quality Assurance responsibilities include ensuring procedures and specifications are followed, reviewing and approving production records, investigating deviations  (non-conformances), determining the acceptability of each batch for release, and for continuously improving the quality system.   This role provides Quality leadership for key initiatives to establish Hillsboro Technical Operations as a center of excellence for aseptic drug product manufacturing. 

• 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.

Who you are:

• You have a BS/MS degree in Science or Engineering  with 15+ years of deep, relevant bio/pharmaceutical experience

• You have significant cross-functional and direct group management, ideally in manufacturing or Quality. Previous experience in Quality is preferred. 

• You are an exceptional leader—able to inspire and motivate teams to make a big impact and deliver their best every day.

• You have experience in working in an FDA regulated environment in a parenteral facility, and in-depth understanding of cGMP, regulatory requirements and quality management systems. 

• You are a strategic and systems thinker with a compliance focus, anticipating technology trends and driving excellence in execution.

• You have experience implementing and driving a continuous improvement culture.

• You are able to work in a dynamic and fast-paced environment while always ensuring the highest quality and safety standards.

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $170,600 - $316,900. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permi