Senior Director, Quality

Senior Director, Quality Assurance - Distribution

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.

• Serve as a key member of the GPD&A Leadership Team, responsible for implementation of cohesive & effective QA processes across the Gilead distribution network and developing medium‑ and long‑term strategic plans for all regions.
• Coach and mentor direct reports to drive independence, development, and performance and provide leadership to ensure a safe, respectful, and inclusive work environment.
• Manage financial budget, resource and workload balance with team to ensure local QA activities are performed to meet timelines and quality & compliance expectations, and key performance indicators are monitored and reported, with key project timelines & milestones tracked.
• Act as Senior QA advisor to in‑country & cluster QA leads, interpreting local & regional regulatory requirements as they pertain to the distribution of Gilead products.
• Act as senior liaison with Gilead’s distribution partners (in US, Canada & LATAM markets) related to escalations & critical/major issues, and changes that impact Gilead’s business models with these partners.
• Interface with regulatory agencies as required, representing Gilead to authorities and regulatory inspectorate bodies.
• Provide leadership for local market activities supporting product recall and support periodic product recall challenges to ensure Gilead’s in‑country distribution operations are in a state of continuous readiness.
• Lead highly complex investigations, including development and implementation of corrective and preventative action (CAPA).
• Partner with QA colleagues to develop strategies, introduce standards, processes & procedures supporting Gilead’s in‑country QA operations.
• Collaborate cross‑functionally and geographically with key stakeholders to establish strong working relationships with quality groups and other functions.
• Act as an internal escalation contact supporting complex and high‑impact quality issues, concerns, and decisions.
• Prime QA representative on cross‑functional regional/global projects & process improvement initiatives of considerable impact to the business.
• Act as deputy for the Executive Director when required, supporting complex and high‑impact quality‑related issues and escalations.

• 14+ years of relevant experience and a bachelor’s degree in science or related fields, or 12+ years of relevant experience and an advanced science degree (MS, MD, Pharm
  
  D, PhD) or an advanced business degree (MBA). Alternatively, 20+ years relevant experience in pharmaceutical warehouse & distribution is required.
• Comprehensive knowledge and experience in quality assurance in highly regulated distribution environments.
• Prior people management experience.
• Broad experience across areas such as customer service, warehouse operations, logistics & transport, with an understanding of Oral Solid Dosage, Parenteral and Aseptic operations.

• In‑depth understanding and application of GDP principles, concepts, and standards in US, Canada…