Director, External Quality Strategy and Operations

Role Summary

Director, External Quality Strategy and Operations responsible for leading a team of Quality Professionals to drive strategy development and implementation of standardized communication, training and rollout of quality standards, requirements, systems and tools across Gilead’s contract organization global network. The role emphasizes cross-functional collaboration, Operational Excellence, and quality transformation initiatives within a biotech/pharmaceutical development environment.

Responsibilities

• Lead cross-functional business and quality process mapping and OpEx initiatives, gathering SME input to design end-to-end processes that improve current approaches using appropriate methodologies and tools.
• Analyze situations and data to identify and resolve problems, applying sound judgment and providing recommendations with high impact implications across multiple PDM Global Quality teams.
• Interface with the PDM Global Quality Leadership Team to drive meaningful process improvements in PDM Global Quality.
• Utilize analytical, communication and influencing skills to drive continuous improvements and meaningful changes.
• Define and align requirements and processes for contract organizations’ quality event management, including deviation/investigation, CAPA, and change control; manage quality agreements and quarterly management review metrics; coordinate annual product quality review.
• Roll out Gilead’s Partner Collaboration Quality System module to the contract organization global network.
• Represent and contribute to Gilead’s Quality Transformation initiatives and collaborate with leaders to achieve business objectives.

Qualifications

• Required: BS in life sciences or relevant business area with 12+ years of post-graduation experience in Pharmaceuticals, Biosciences or related industry; OR MS with 10+ years; OR PhD with 8+ years.
• Required: Experience leading cross-functional biopharma strategic initiatives.
• Required: Experience leading business process mapping with diverse stakeholders and SMEs.
• Required: Experience with business process mapping tools such as Visio.
• Required: Strong interpersonal and conflict resolution skills; solid understanding of current industry, quality and compliance trends; ability to simplify complex situations; excellent verbal and written communication.

Education

• BS in life sciences or a relevant field; or MS/PhD with corresponding years of relevant experience as noted in qualifications.

Skills

• Cross-functional leadership and collaboration
• Operational Excellence (OpEx) in quality environments
• Quality event management, deviation/investigation, CAPA, change control
• Process mapping and business process management
• Analytical reasoning and data-driven decision making
• Stakeholder management and influencing skills