Senior Device Quality Manager

Who we are

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.

Genentech is the founder of the biotechnology industry and has been delivering on the promise of biotechnology for more than 43 years. It has been a member of the Roche Group since 2009 and is one of its most important centres of pharmaceutical research. At Roche, the patient is at the heart of all R&D efforts, and delivering life-changing therapies to patients while also driving positive change in the global society is the impetus to everything we do.

This role is based in the Global Device Quality Management organization which has the end-to-end responsibility of leading and managing the quality aspects of developing medical devices, drug-device combination products and packaging to deliver the pharmaceutical pipeline. We provide oversight for the development, implementation, and continuous improvement of device-related quality processes and procedures as well as technical and compliance guidance considering the relevant standards and regulatory requirements for medical devices, combination products and packaging.

We work closely with device development and device lifecycle teams during development and manufacturing to ensure product integrity to design and manufacturing process specifications. We leverage our external partners in order to offer flexibility and know-how to our internal capacity, at the right cost and quality. We enable our partners to reliably deliver compliant, quality products to our supply chain customers, so that we can meet the needs of patients worldwide.

We accomplish our mission through cross-functional collaboration focused on continuous improvement, embedding quality and reliability into the design, and ensuring quality process excellence.

The Opportunity

As an integral part of Global Device Quality Management, you will collaborate with device and packaging development as well as device lifecycle teams and play an important role in a matrix organization to provide:

• Subject Matter Expertise (SME) on design control, risk management, test method validation and statistical evaluations for device/combination products
• Quality engineering leadership/guidance to facilitate the intentional integration of quality and reliability into the design development effort, thereby ensuring the development of design that is inherently of high quality and reliability
• Quality assurance oversight of internal partners and external GxP suppliers including CMOs to ensure compliance with regulations, standards and Roche requirements for the development, manufacturing, and post market quality oversight for medical devices and combination products
• Oversight of all required quality activities during the lifecycle of a GxP supplier (Source & Select, Implement, Manage, and Decommission), including but not limited to: method validations, Roche and Health Authority audits, complex investigations, complaint handling, and regulatory submissions, act as SME in Supplier Qualification and Maintenance audits
• Quality focused project management expertise by acting as the Quality Single Point of Contact (QSPOC) in device and packaging projects by liaising with internal and external partners, thereby ensuring cohesive and coordinated quality support for the development, manufacture and sustainment of devices and combination products

Who you are

You are someone who wants to influence your own development and can work independently, with limited supervision. You are looking for a company where you have the opportunity to pursue your interests across functions and geographies; where a job title is not considered the final definition of who you are, but the starting point.

You have a Degree in an Engineering or Science discipline. You bring 4-6 years of experience in quality functions (device quality preferred) and relevant operational experience leading and/or working with internal and external teams through end-to-end projects. You have a thorough understanding of the biotechnology industry and specifically of combination products and medical devices. You have working knowledge of ISO 13485, 21 CFR 820, EU MDR and ISO 14971. You have a sound understanding of both Quality Compliance and Quality Engineering.

Preferred

• Ability to educate teams and organization on Design Controls as it applies to medical devices and combination products, and related topics
• Demonstrated capability of applying risk management concepts and tools
• Well-developed teamwork and collaboration skills and ability to communicate clearly and professionally both verbally and in writing. Fluency in English is a must
• Demonstrated problem solving and decision making skills including hands-on working experience with quality-related tools, Six Sigma / DMAIC is preferred
• Experience in working in agile environment and usage of lean tools
• ASQ CQE certification is a plus (but not required)

This position requires up to 20% travel

Relocation benefits are not available for this posting.

The expected salary range for this position based on the primary location of California is $112,000 to $208,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

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Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.