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Computer Systems Auditor South San Francisco, California

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 South San Francisco, CA, headquarters:

Computer Systems Auditor

Responsibilities: The candidate will participate in or lead audits (internal system deployment, external contract organization, software vendor) and develop audit findings that address individual gaps as well as system gaps. He/she will identify gaps in corporate practices, policies and procedures and act in the role of Response Manager (internal / external audits). The candidate is primarily responsible for ensuring response review and any necessary customer negotiation with minimal oversight from supervisor. He/she will ensure communication of response information to Data Management and present audit outcomes to system, site, functional unit (e.g., Informatics, Quality, Manufacturing, etc.) or PTQG Leadership Team(s). The candidate will be assigned compliance opinions and assessments. He/she will participate in corporate/site document development and identify gaps in proposed corporate/site practices, policies and procedures. He/she will participate as a PTQGC representative in team meetings and provide input on issues discussed with minimal manager oversight. The candidate will have the ability to develop and present technical material to department and/or internal audiences with some management oversight.


Requirements
A Bachelor’s degree, Master’s degree or equivalent, preferably in engineering or computer technology, is required. The candidate must have a solid understanding of software development methodologies. A minimum of five years applicable technical experience including work in a regulated GMP/QSR environment is required. Experience auditing software/hardware providers and/or GMP implementation or equivalent experience in audit related activities would be considered. An in depth knowledge of GMPs/QSR along with knowledge of other relevant computer system guidance and standards is required. The candidate must be able to interpret and apply regulations and standards to Roche operations and with minimal supervision. He/she must be able to apply appropriate standards during external audits (i.e., software / hardware vendor, contract organization) with minimal supervision. Approximately 25% or more travel is required.

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=00379336&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.