Associate Director, Clinical Data Science Compliance Oversight

Role Summary

Associate Director, Clinical Data Science Compliance Oversight at Gilead. Lead in developing and implementing quality strategy to support CDS objectives, ensure regulatory compliance, and drive continuous improvement within the CDS organization.

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

Qualifications

• Bachelor's Degree and Ten Years‚Äô Experience
• OR Masters' Degree And Eight Years‚Äô Experience
• OR PhD And Two Years‚Äô Experience

Preferred Qualifications

• 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‚Äôs 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)

Knowledge & Other Requirements

• 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

People Leader Accountabilities

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.