Senior Manager, Quality Assurance- Global Product Distribution & Affiliates

For Current Gilead Employees and Contractors:

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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.

Job Description
 

Responsibilities:

• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements as it pertains to a US and Global product distribution operation.

• Maintains routine programs and processes to ensure high quality products and compliance with FDA current Good Distribution Practice (GDP) and National Association or Boards of Pharmacies (NABP) Verified-Accredited Wholesale Distributors (VAWD) requirements. 

• Supports Global and Regional QA teams as well as working cross-functionally with Global Logistics, Supply Chain, Warehouse, Customer Service personnel as well as facilities, EHS and validation colleagues in all aspects of product distribution.

• Interfaces with and provides QA oversight of contracted 3PL activities pertaining to product distribution and process performance issues.

• Participates in developing Standard Operating Procedures (SOPs) and other types of documentation to ensure quality objectives are met. 

• Reviews shipping records, environmental monitoring and associated data relating to product distribution activities.

• Hosts NAPB external audits and interacts closely with external regulators/stakeholders. 

• Co-hosts/supports external FDA audits and internal audit programs.

• Participates in the development & delivery of training programs regarding relevant to US and Global product Distribution.

• Conducts or serves as a coordinator of investigations and corrective and preventive action (CAPA) recommendations as well as Change Management related to QA Operations.

• Conducts gap analyses and risk assessments of processes & procedures against relevant GDP guidelines as well as corporate standards. 

• Participate in or where relevant lead local and corporate projects and process improvement initiatives, as required.

Knowledge, Experience & Behaviors:

• Experience in US market and international product distribution, to include supporting/hosting FDA and State Pharmacy Board inspections.

• Demonstrates proficiency in Good Distribution Practices (GDP), Verified-Accredited Wholesale Distributors (VAWD) and Drug Supply Chain Security Act (DSCSA) requirements. 

• Demonstrates working knowledge with good proficiency in Microsoft Office applications. 

• Experience in providing QA oversight of contracted 3PL activities. 

• Resilient profile with the ability to deliver in a challenging environment. 

• Ability to engage and manage multiple stakeholders to achieve the objective. 

• Organised with systematic approach to prioritisation.