Lead in the development and implementation of quality strategy and associated capabilities to support the CDS objectives
Manage quality review of clinical trial documents, workflows, and outputs within the CDS organization to ensure clinical trials are conducted in compliance with Gilead procedures, GCP and applicable global regulations
Analyze trends to identify process gaps, improvement opportunities and areas requiring corrective/preventive actions
Lead new quality focused initiatives focused on new learnings, findings, and observations to continuously improve CDS quality practices and methods
Work closely with Gilead CDS study team to provide expert advice on compliance issues and risk mitigation actions
Collaborate with the audit, inspection and CAPA management team within Gilead R&D Quality on internal audits, regulatory agency inspections, risk assessment, deviations and CAPA activities
Liaison and coordinate with business experts and stakeholders to support resolution of audit outcomes which require further action or response
Partner closely with business units to lead, track and manage corrective actions or risk mitigation activities
Serve as a Change Champion for Gilead QMS-related communications to the CDS organization consolidating and channeling just-in-time information and resources to prepare the organization for change
Analyze new regulations and polices with emphasis Good Clinical Practices (GCP) and partner with business experts and stakeholders to update internal documentation and practices accordingly based on areas of impact
Foster a commitment to quality in individuals and a culture of quality across the CDS organization and with CDS related service providers
Requirements
Bachelor's Degree and Ten Years’ Experience OR Masters' Degree and Eight Years’ Experience OR PhD and Two Years’ Experience
10 years of relevant experience with a BS degree in life sciences or related field with significant experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization and mitigation, and vendor management
8 years of relevant experience with a Master’s degree in life sciences or related field with significant experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization and mitigation, and vendor management
Experience working across a broad spectrum of quality and compliance activities, including authoring and reviewing SOPs, facilitating internal audits, supporting regulatory inspections, developing and managing CAPAs and deviations, and training others on quality and compliance requirements
Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities
Familiar with the practice of recording and monitoring quality observations through a Quality Management System (QMS)
Benefits
company-sponsored medical, dental, vision, and life insurance plans
discretionary annual bonus
discretionary stock-based long-term incentives (eligibility may vary based on role)
paid time off
Job title
Associate Director, Clinical Data Science Compliance Oversight
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