Director, External Quality Strategy And Operations

Associate Director/Director, Quality Management

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Gilead Sciences PDM External Quality is currently seeking a leader at the Associate Director/Director level to lead a team of Quality Professionals to drive strategy development and implementation of standardized communication, training and rollout of Gilead's Quality standards, requirements, systems and tools to the Gilead's contract organization global network.

• The successful candidate must possess expertise in leading cross-functional business and quality process mapping, identifying improvements to existing business and quality processes and leading Operational Excellence (OpEx) initiatives that span multiple PDM External Quality teams.
• Being able to utilize the tools & training associated with business process management in a strategic capacity.
• Responsible for the management of quality agreement, coordination of quarterly management review metrics collection, annual product quality review.
• Define and align the requirements and processes for contract organizations' quality event management inclusive of deviation and investigation, corrective and preventative action, and change control.
• Successfully and consistently roll out Gilead's Partner Collaboration Quality System module to Gilead's contract organization global network.
• Key representative for Gilead's Quality Transformation initiatives.
• The leader must be able to evaluate options and trade-offs and utilize available resources to achieve the most positive impact on the business and be able to partner with leaders in PDM External Quality and Global Quality to achieve business objectives.
• The successful candidate must have proven track records in leading Operational Excellence in Quality organization in a biotech or pharmaceutical development environment and strong knowledge of cGMP quality systems.

Job Functions:

• Lead cross-functional business and quality process mapping and OpEx initiatives.
• Ability to analyze situations and/or data, applying sound judgment and reasoning, to identify and resolve problems and make recommendations.
• Interface with members of the PDM Global Quality Leadership Team to drive meaningful process improvements in PDM Global Quality.
• Utilize excellent analytical, communication and influencing skills, as well as a keen problem-solving ability, to drive helpful changes and continuous improvements.

Basic Qualifications:

• A BS in life sciences or a relevant business area with 12+ years of varied post-graduation experience in Pharmaceuticals, Biosciences or a related industry required OR
• MS with 10+ years of relevant experience OR
• PhD with 8+ years of relevant experience
• Experience leading cross-functional biopharma strategic initiatives.
• Experience leading business process mapping with a variety of stakeholders and SMEs.
• Experience with business process mapping tools such as Visio.
• Strong interpersonal skills and conflict resolution skills.
• Solid understanding of current industry, quality and compliance trends.
• Demonstrated ability to understand complex and complicated situations and to strip out complications.
• Outstanding verbal and written communication skills with the ability to effectively interact with all levels within the organization.

The salary range for this position is: Bay Area: $210,375.00 - $272,250.00. Other US Locations: $191,250.00 - $247,500.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.