San Francisco, CA
11 - 15 years
Posted 178 days ago
Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives, compliance requirements as well as a scientific/clinical understanding of the clinical or non-clinical program. Leads the conduct of internal and external audits to assess compliance with GCP/GLP regulatory requirements for Sponsor studies. Provides Drug development Teams with clear and fact-based GCP/GLP audit results regarding the conduct of clinical or non-clinical studies. Provides guidance to process owners so that effective corrective and preventative actions (CAPAs) are implemented to resolve areas of non-compliance. Performs audits of data sources to assess integrity of research data and other data, as required, which support data summaries and conclusions for regulatory filings, due diligence, presentations/publications, etc. May evaluate and select contractauditors to help perform requiredaudits. Develops proactive approaches to implement quality standards, including input to procedures and systems which support GCP compliance requirements for the conduct of clinical studies. Provides GCP/GLP training programs in functional areas involved in the execution of GCP/GLP regulated studies. Has liaison responsibility for interactions with regulatory agency inspectors during GCP/GLP inspections of Sponsor studies/activities and coordinates follow-up actions and responses to address inspection findings. Assesses GCP/GLP deviations and determines adequacy of reporting and the potential impact on the study. Provides guidance and information on GCP/GLP regulations, standards, and quality systems. Interacts with internal senior management and external service providers/CRO's senior management on GCP/GLP quality matters. Represents GCP/GLP compliance function on various working teams, other functional areas and with external partners. Interacts with other Corporate Quality personnel to ensure alignment of quality standards and systems. Keeps current on changes in industry and regulatory standards for GCP/GLP requirements and advises on business impact. Participates with other senior managers to establish strategic plans and objectives. Ensures appropriate documentation of activities is developed, implemented and maintained. Provides input to the preparation of documents for internal reports, external partner reports and/or regulatory filings. Directs and coordinates the activities of GCP/GLP quality projects with responsibility for results with relationship to cost, methods and employees. Supports the implementation of quality improvement initiatives for company operations. Directs operation and compliance activities with other applicable groups to establish timelines and accomplish tasks/projects. This includes helping drive the development, content, and implementation of SOPs and Work Instructions within GCP/GLP Compliance and other Nektar Drug Development departments. May direct other quality staff and/or functions.
A minimum of a Bachelors degree in a scientific discipline is required; an advanced degree is preferred. Equivalent experience may be accepted. A minimum of 10 years experience in the pharmaceutical or other related industry is required. A minimum of 8 years working experience in a Quality environment with expert knowledge and hands-on experience with GCP/GLP audits a must. Comprehensive knowledge of GCP/GLP regulations and the ability to correctly interpret minimum standards are a must. Experience with documentation systems, document review and auditing responsibilities is required. Experience with clinical/non-clinical research/development and operations for execution of studies is required. Working knowledge in quality sciences, statistics, and computer-based operations is required. Must be highly detail-oriented and have a high analytical aptitude. Strong verbal and written communication skills, as well as interpersonal and influencing are required. Must be goal-oriented, quality-conscientious, and customer-focused to deliver results. Experience working in a cross-functional team environment is required. Excellent computer skills are required. Up to 25% travelrequired.