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Compliance Specialist (Auditor) Responsibilities: Applies a complete and technical understanding of Good Clinical Practice (GCP) regulations/guidelines to independently address a variety of complex issues associated with drug development. Has expert knowledge of and is able to apply the FDA and ICH regulations and guidelines and other applicable regulations and guidelines. Coordinates and assigns audits. Performs assigned audits,including internal system audits, external vendor audits, Clinical Investigator Site Audits, and reviews of documents to be submitted to regulatory authorities. During audits, identifies compliance risks and reports findings to appropriate management with recommendations for resolution. Understands and evaluates clinical sites for compliance with the requirements for informed consent forms, case report forms, and essential documents for the trial master files and regulatory affairs files. Performs or reviews complex literature/database searches for additional or supporting compliance information, when appropriate. Uses this information to provide well-informed audit findings and recommend corrective/preventive actions, develop compliance opinions, and provide education or training to GCP functional areas. Researches and writes formal DCLC Compliance Opinions or provides other verbal/written guidance on complex compliances issues. Reviews Compliance Opinions prepared by E2 and E3 prior to distribution. Has considerable latitude in determining objectives and approaches to problem solving. Regularly interacts with co-workers, management, Development personnel and partners in other Genentech departments (e.g., Legal, Regulatory Affairs) regarding compliance issue resolution and system improvements. Demonstrates ability to influence and negotiate effective solutions. Develops specific audit plans, leads, independently performs, or trains other auditors to perform complex compliance audits and facilitates resolution of audit issues. Coordinates compliance projects. Assists DCLC management with strategic planning. Represents DCLC (Development GCP/GLP Compliance) to Development through activities such as CCG Molecule Lead (including implementation team [IT) membership) and DCLC Liaison to Pharm SubTeams. Assists the Inspection Management team during FDA or other regulatory authority inspections of Genentech Development studies. Such assistance may include document retrieval/review and preparation/training of perspective interviewees. Internally provides training presentations in audit or regulatory trends, procedures for audit responses, and other topics. Provides compliance guidance to all audited parties to encourage process improvements. Externally presents GCP training at Investigator Meetings. Is a recognized trainer of DCLC auditors.
Requirements: Highly skilled auditor who demonstrates an in-depth understanding of complex regulations, guidelines, quality systems, and compliance issues. Is proficient as lead auditor and trainer. Has proven ability to assimilate new and emerging compliance information or trends. Serves as an internal consultant in interpretation of regulatory requirements and expectations. Excellent verbal, written communication skills and presentation skills are a must. BA/BS in life sciences (MS, RN or pharmacy degree preferreda minimum of 7 years industry experience, and 3 to 5 years experience auditing to GCP, or 9 years clinical operations/research experience and 7 years compliance-related experience. Domestic and international travel required (30-40%).
One of the largest and most respected biotechnology companyin the world, HQ'd in the United States