Gilead is looking to solve the problem of ensuring quality and compliance in clinical trials and drug development, and is seeking a leader to develop and implement quality strategies and capabilities to support this goal.
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
- 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
- Familiar with the practice of recording and monitoring quality observations through a Quality Management System (QMS)
- 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
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
Other
- 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
- Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account
- Bachelor's Degree and Ten Years’ Experience OR Masters' Degree and Eight Years’ Experience OR PhD and Two Years’ Experience
- Strong track record of leadership and management experience
