PhD candidate specializing in Data Science & Machine Learning at BMW Group, focusing on innovative solutions for electric vehicle charging infrastructure.
About the role
- Associate Director overseeing clinical data compliance at Gilead. Leading quality initiatives and advising on regulatory standards and practices for clinical trials.
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
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
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