About 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. 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.
Responsibilities
- Provide quality oversight for all cGMP operations, ensuring products meet quality standards and regulatory requirements.
- Create an environment with strong team spirit, timely and effective communication, sense of urgency and high motivation.
- Support product launches through all stages of Regulatory relevant activities, including successfully managing inspections.
- Drive site strategy realization, networking activities, coordination, cross-functional planning and decision making.
- Promote a positive safety culture and ensure all applicable safety, health and environmental requirements are met.
- Embody Pharma Technical (PT) Lean principles and methodologies and promote a continuous improvement culture.
- Optimize and protect the Quality operating model, adapting to current and future needs of the organization.
- Partner with Manufacturing, Manufacturing Sciences and Technology, and Engineering Quality for efficient manufacturing execution.
- Help establish HTO as a center of excellence for Drug Product Manufacturing including all unit operations.
Requirements
- BS/MS degree in Science or Engineering.
- 15+ years of deep, relevant bio/pharmaceutical experience.
- Significant cross-functional and direct group management experience, ideally in manufacturing or Quality.
- Exceptional leadership skills to inspire and motivate teams.
- Experience in an FDA regulated environment in a parenteral facility.
- In-depth understanding of cGMP, regulatory requirements and quality management systems.
- Strategic and systems thinker with a compliance focus.
- Experience implementing and driving a continuous improvement culture.
- Ability to work in a dynamic and fast-paced environment while ensuring high quality and safety standards.
Benefits
- Relocation benefits are provided.
