Genentech · 2 days ago
Director, Drug Product Quality Assurance
Hillsboro, OR
Full-time
Onsite
Director/Executive
$143K/yr - $263K/yr
15+ years expGenentech is a drug product and finished goods manufacturing organization responsible for delivering life-saving medicines. The Director of Drug Product Quality Assurance will lead the Quality Assurance team, ensuring compliance and continuous improvement in cGMP operations while providing quality oversight for products and driving site strategy.
BiotechnologyLife ScienceManufacturing
Responsibilities
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
Qualification
Required
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
Benefits
Relocation benefits are provided
Company
Genentech
Genentech is a biotechnology research company that specializes in genetic testing and personalized medicines.
10001+ employees
H1B Sponsorship
Genentech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (167)
2024 (148)
2023 (150)
2022 (178)
2021 (121)
2020 (158)
Funding
Current Stage
Public CompanyTotal Funding
unknown2009-03-26Acquired
1999-07-20IPO
1976-01-01Series Unknown
Leadership Team
Ashley Magargee
CEO
Michael Laird
Vice President
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