Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet need. With each new discovery and experimental drug candidate, we seek to improve the care of patients suffering from life-threatening diseases.

Gileads primary areas of focus include HIV/AIDS, liver disease and serious cardiovascular, cardiopoulmonary and respiratory conditions.

Our portfolio of 12 marketed products includes a number of category firsts and market leaders, including Atripla (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) - the first single-tablet regimen for HIV infection. Gilead has recently made significant investments into the Cardio-Pulmonary and Respiratory disease and markets Letairis for Pulmonary Arterial Hypertension and Ranexa for Chronic Angina. Gileads pipeline in these areas includes products for patients suffering from Cystic Fibrosis, resistant hypertension as well as a variety of other conditions.

Specific Responsibilities:
• Previous experience in the pharmaceutical or CRO industry implementing and validating computer systems managing regulated information.
• Experienced in conducting electronic system related audits of CROs including EDC, IVRS, imaging and cardiac monitoring vendors. Additional experience auditing software vendors.
• Experienced in implementing biometrics, statistical programming, and data management processes and procedures.
• Experienced in implementing procedures for the management of electronic information by CRO / vendors and the transfer of this information internally.
• Experienced in the prospective and retrospective validations of both COTS and in-house developed systems.
• Experienced in performing 21 CFR Part 11 assessments (gap analyses) and developing corrective action plans
• Knowledgeable of SDLC and IT related development processes and procedures
• Experienced in using, implementing, and/or validating all or most of the following types of systems: drug safety, medical/drug coding, clinical trial management, clinical information, electronic data capture, electronic diary, radiological reading, laboratory information management, medical information systems, computerized laboratory instrumentation, document/enterprise content management, submission publishing, electronic transfer/exchange, structured product labelling, training records, CAPA, and audit tracking systems
• Experienced in developing procedures for validation, 21 CFR Part 11 compliance, electronic systems compliance, and/or IT operational procedures
• Experienced in infrastructure qualification.
• Knowledgeable in 21 CFR Part 11, GCP, GLP, GMP, applicable FDA guidance, and international regulations applicable to electronic systems.

Essential Duties and Job Functions:
• Consult with, assist, and train business areas that implement technology, processes, and procedures that manage electronic records and/or signatures to ensure compliance with regulatory agency regulations.
• Work with business unit areas and IT to develop appropriate business requirements, and evaluate technology that will meet regulatory and business electronic record keeping and electronic signature requirements.
• Assist the business areas in achieving compliance with 21 CFR Part 11, other applicable regulations, and GSI policies/procedures related to electronic systems compliance
- Provide oversight of the computer validation and the 21 CFR Part 11 compliance program
• Schedule, conduct, and assist in CRO/service provider audits, audits of software vendors, and in-house audits
• Conduct 21 CFR Part 11 assessments and assist the business areas and IT in developing corrective action plans
• Conduct training related to 21 CFR Part 11, validation, other regulatory agency regulations / guidances and GSI electronic system compliance related policies/procedures
• Work with business units to ensure that up-to-date computer system inventories and assessments of regulated systems are maintained

Knowledge, Experience and Skills:
• 8+ years of relevant experience and a BS.
• 6+ years of relevant experience and an MS.
• Relevant work experience consists of working in a pharmaceutical quality control, quality assurance or compliance environment.

To apply, please submit resume to Tricia Collins at tcollins@gilead.com or for more information call 650-522-1852. Gilead is an equal opportunity employer.

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