Senior Auditor

Responsibilities:The CSC Auditor is responsible for conducting compliance audits of computerized systems in support of GXP activities, both internally and at contract sites. Additionally, external audits include software vendor qualification/follow-up audits. The candidate will plan, organize and execute audits that result in a written and/or verbal report on quality/compliance related activities for information technology system and application development, validation implementation and maintenance to assure the quality and the integrity of the data collected from these systems. He/she will provide expertise and guidance in interpreting FDA regulations and ICH guidelines to assure compliance of computer programs and systems, computational software, clinical technologies, manufacturing technologies and the integration of information technology. Requirements:A Bachelor’s degree in a technical discipline (Information/Computer Sciences or Engineering) or equivalent is required. The candidate must have a minimum of five years of direct experience with the development, implementation and/or validation of computerized systems in a regulated environment. This position requires a solid foundation in various computer systems used in the bio-pharmaceutical industry, working knowledge of the business processes associated with product development, clinical research and/or manufacturing of drug products (including medical devices) and an understanding of the applicable regulations that impact computer systems (21 CFR Parts 11, 58, 211, 312, 820). A familiarity with industry guidelines and best practices regarding the validation and documentation of computer systems (PDA 18, GAMP, IEEE) is also required. Excellent interpersonal skills, including written and verbal communication are essential. The candidate must possess the ability to write audit observations clearly and concisely with a solid understanding of software development methodologies. Knowledge of general good programming practices and software testing experience is a must. He/she must have the ability to read and evaluate the quality of system design documentation and data base design specifications. The ability to travel approximately 25% - 30% of the time is required. Genentech is dedicated to fostering an environment that is inclusive and encourages diversity of thought, style, skills and perspective. To learn more about our current opportunities, please visit: www.gene.com/careers and reference Req. #1000019674. Please use “Web – Monster” when a "source" is requested. Genentech is an Equal Opportunity Employer.