Senior Manager/Director, Quality Engineering and Validation (HTO)

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.

Leadership:

• 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 be an active and visible change agent and promote a flexible and open attitude towards new opportunities.
• 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.

Technical and functional tasks:

• 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.
• 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 support product launches through all stages of Regulatory relevant activities, including successfully managing inspections.
• You will provide quality oversight for all product complaint investigations and ensure robust, comprehensive investigations and effective corrective and preventative actions.

Who you are:

• You hold a B.S/M.S degree, preferably in Science or Engineering related fields with deep, relevant bio/pharmaceutical experience (8-11 years for Senior Manager, 12 - 15 for Director)
• You have significant cross-functional and direct group management, ideally in manufacturing or Quality. Previous experience in Quality and/or Technical Validation 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 $122,000 - $227,000 for the Senior Manager level or $142,000 - $263,600 for the Director level. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for the benefits detailed at the link provided below.

Link to Benefits

Relocation benefits are provided

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Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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