Genentech-posted 8 months ago
$122,000 - $263,600/Yr
Full-time • Senior
Hillsboro, OR
Chemical Manufacturing

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: Quality Engineering & Validation (QEV) works in a very dynamic environment in both the commercial and new product technical transfer environments. The close networking with the local and global organization makes QEV a key function in the E2E business. The Head of Quality Engineering & Validation is accountable for quality oversight for all qualification and validation activities supporting the introduction of new products (technical transfers), implementation of new facility expansions, new technologies and end-to-end Quality Engineering and Validation support at our aseptic manufacturing site in Hillsboro, OR, and anchoring sustainably within the site. Quality oversight is inclusive of the equipment, facility and utility systems, GMP computerized systems, drug product manufacturing processes, cleaning processes, sterilization processes, and analytical methods. In this exciting role, you will lead a team of motivated Quality engineers and validation professionals to establish Hillsboro Technical Operations as a center of excellence for aseptic drug product manufacturing.

  • Create an environment with strong team spirit, timely and effective communication, sense of urgency and high motivation.
  • Inspire teams to achieve short-term and long-term goals.
  • Drive site strategy realization, networking activities, coordination, cross-functional planning and decision making.
  • Promote a positive safety culture and ensure compliance with safety, health and environmental requirements.
  • Embark on Pharma Technical (PT) Lean principles and methodologies to promote a continuous improvement culture.
  • Establish HTO as a center of excellence for Drug Product Manufacturing including all unit operations.
  • Partner with Manufacturing, Manufacturing Sciences and Technology, and Engineering Quality for efficient manufacturing execution.
  • Support product launches through all stages of Regulatory relevant activities.
  • Provide quality oversight for all product complaint investigations.
  • B.S/M.S degree, preferably in Science or Engineering related fields.
  • 8-11 years of relevant bio/pharmaceutical experience for Senior Manager level.
  • 12-15 years of relevant bio/pharmaceutical experience for Director level.
  • Significant cross-functional and direct group management experience, ideally in manufacturing or Quality.
  • Previous experience in Quality and/or Technical Validation is preferred.
  • Experience in an FDA regulated environment in a parenteral facility.
  • In-depth understanding of cGMP, regulatory requirements and quality management systems.
  • Ability to work in a dynamic and fast-paced environment while ensuring high quality and safety standards.
  • Experience implementing and driving a continuous improvement culture.
  • Strategic and systems thinker with a compliance focus.
  • Relocation benefits are provided.
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