Director, External Quality Strategy and Operations

Role Summary

Director, External Quality Strategy and Operations at Gilead Sciences PDM External Quality. Lead a team of Quality Professionals to drive strategy development and implement standardized communication, training, and rollout of Gilead’s Quality standards, requirements, systems, and tools across the contract organization global network. Focus on cross-functional OpEx initiatives, quality event management, and quality transformation initiatives to positively impact the business.

Responsibilities

• Lead cross-functional business and quality process mapping and OpEx initiatives, facilitating input from SMEs to design end-to-end processes that improve current approaches.
• Analyze situations and data to identify and resolve high-impact issues affecting multiple PDM Global Quality teams.
• Interface with the PDM Global Quality Leadership Team to drive meaningful process improvements.
• Roll out Partner Collaboration Quality System module to the contract organization global network.
• Manage quality agreements, coordinate quarterly management review metrics, and oversee the annual product quality review.
• Define and align requirements and processes for contract organizations‚Äô quality event management, including deviation/investigation, CAPA, and change control.
• Represent Gilead‚Äôs Quality Transformation initiatives.
• Evaluate options and trade-offs, leveraging resources to maximize business impact and partner with Global Quality leaders to achieve objectives.

Qualifications

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

Skills

• Operational Excellence (OpEx) in a biotech/pharmaceutical development environment
• Quality systems and cGMP knowledge
• Cross-functional collaboration and stakeholder management
• Analytical thinking, problem-solving, and data-driven decision making
• Facilitation and influence to drive process improvements

Education

• BS in life sciences or related field; or MS/PhD with relevant experience (as listed in Qualifications).

Additional Requirements

• Location specifics not provided in source; travel expectations not specified.