Associate Director, Quality CDS Business Strategy and Operations

The Associate Director, Quality will be responsible for designing, implementing, and optimizing quality capabilities that support the Clinical Data Science (CDS) to drive a culture of continuous improvement and raise awareness about the importance of a Quality Culture and shared accountability for the Gilead R&D Quality Management System (QMS). This role requires an in-depth knowledge of GCP and understanding of regulatory requirements applicable to the conduct of clinical trials. The Associate Director, Quality will partner with key stakeholders in Gilead R&D Quality to enhance quality across the trial portfolio to address compliance issues and conduct risk control and risk mitigation activities.

Job Responsibilities:

• 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

Education and Experience:

• A BS/BA degree in life sciences or related field with 10+ years of relevant experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization and mitigation, and vendor management OR
• A MS/MA degree in life sciences or related field with 8+ years of relevant experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization and mitigation, and vendor management

Knowledge & Other Requirements:

• 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)
• In-depth knowledge of regulatory requirements applicable to the conduct of clinical trials and guidelines (e.g., FDA, EMA, ICH) and related industry standards and trends
• Through knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing
• Strong analytical skills to assess quality issues and lead the resolution in a collaborative manner across functions
• Significant experience advising business function and senior leadership team on quality & compliance requirements, evolving regulation, risk mitigation, and continuous improvement
• Strong track record of cultivating and maintaining strategic relationships and collaboration both internally and externally