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Passionate About Science We’re passionate and rigorous about our science. For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using innovative science to develop breakthrough medicines that improve the lives of people with serious or life-threatening diseases.

The following opportunity exists in our Hillsboro, OR location:

Senior Technical Manager Quality Risk Management

Responsibilities: The Senior Technical Manager acts as key point of contact for Quality Assurance to ensure successful development, deployment and maintenance of the Quality Risk Management (QRM) program. The candidate will partner with Engineering to ensure use of Quality Risk Management and Risk Based Validation in accordance with cGMP regulations and Genentech standards.

The candidate will integrate QRM into routine operations and the Quality System. He/she will train personnel and internal customers on risk management business processes. He/she will serve as a technical subject matter expert (SME) on Quality systems, processes, and issues in support of departmental functions. The individual will make decisions that impact the goals and objectives of the organization, and also make recommendations regarding best options to influence decisions. He/she may provide guidance and manage work activities of other staff members for specific projects or objectives.

A Bachelor’s degree, preferably in Science or Engineering, and at least eight years experience in the medical device, pharmaceutical, biopharmaceutical, or related industry, or an equivalent combination of education and experience is required. He/she must have direct experience in a Quality role supporting Operations in a commercial GMP facility. The candidate must have experience applying process improvement tools and methodologies such as LEAN/Six Sigma. He/she must have demonstrated practical risk management skills, including facilitation using risk management tools. The individual must have a sound knowledge of cGMPs or Quality System regulations. Biotech/pharmaceutical industry experience a plus. The candidate must have the ability to interpret and relate Quality standards for implementation and review.

Passionate About Our People We recognize that our people are our most important asset. It’s why we foster an inclusive environment that encourages diversity and offer competitive healthcare and benefits to help you bring the best to the business and to your personal life. Join us as we continue to tackle medicine’s most challenging problems and live a life inspired. To apply for this job, visit https://roche.taleo.net/careersection/test/jobapply.ftl?lang=en&job=00387822&src=JB-11480

Now a member of the Roche Group, Genentech has multiple medicines on the market for cancer and other serious illnesses. We are an equal opportunity employer.