Job Description

Job Description

At Gilead, were creating a healthier world for all people. For more than 35 years, weve 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 worlds biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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

As the Associate Director, Quality Assurance - Global Product Distribution & Affiliates, your key responsibilities will be:

• Serve as a key member of the QA Global Supply Chain team who are collectively responsible for implementation of cohesive & effective QA processes across the Gilead distribution network as well as developing medium and long-term strategic plans with our Global Logistics (Commercial & Clinical), and Supply Planning business partners, which support the overall strategic plans for the Supply Chain & Quality organizations.
• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements as part of a QA team supporting Gileads global logistics operations.
• Serves as a project lead within the function or leads functional modules on large scale cross functional projects.
• Maintains routine programs and processes to ensure high quality products and compliance with EU & FDA current Good Distribution Practice (GDP) and National Association of 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, Global Supply Planning, Warehouse, Customer Service personnel as well as Trade Operations, Regulatory Affairs and Validation/Packaging Engineering.
• 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.
• Co-hosts/supports external FDA/NABP inspections and internal audit programs.
• Participates in the development & delivery of training programs relevant to 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.
  
• Demonstrates in-depth understanding and application of Global GDP principles, concepts, best practices and standards.
• Experience in Global Product storage & distribution, including cold chain and Ultra-Low Temperature materials.
• Is able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.
• Anticipates shifts in industry trends and regulatory environment that will impact Gileads business needs and positions the function to respond accordingly.
• Is able to develop solutions to complex problems, which require a high degree of ingenuity, creativity, and innovativeness, and where precedent may not exist.
• Demonstrates extensive knowledge of industry best practices and trends.
• Demonstrates excellent verbal, written, and interpersonal communication skills, as well as excellent influencing skills.
• Is comfortable interacting with regulatory agencies as needed and possesses the ability to represent Gilead in public forums.
• Demonstrates the ability to identify, understand and exceed customer expectations.
• Demonstrates experience and ability to manage staff.
• Demonstrates the ability to initiate and support change and respond to change requirements by continually striving to improve process or business areas, consistent with organizational strategy.
  

Basic Qualifications:

10+ Years with BS/BA
OR
8+ Years with MS/MA or MBA

Preferred Qualifications:

• 10+years of relevant experience and a Bachelors degree in science or related fields, or 8+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA. Alternatively, 20+years relevant experience in pharmaceutical warehouse & distribution required.
• Comprehensive knowledge and experience in quality assurance in highly regulated distribution environments.
• Broad experience across areas like customer service, warehouse operations, logistics & transport required and understanding of Oral Solid Dosage, Parenteral and Aseptic operations is beneficial.
  

People leader accountabilities:

Create inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

Develop talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

Empower teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

The salary range for this position is: $182,070.00 - $235,620.00. 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*.

Job Description

At Gilead, were creating a healthier world for all people. For more than 35 years, weve 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 worlds biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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.

As the Associate Director, Quality Assurance - Global Product Distribution & Affiliates, your key responsibilities will be:

• Serve as a key member of the QA Global Supply Chain team who are collectively responsible for implementation of cohesive & effective QA processes across the Gilead distribution network as well as developing medium and long-term strategic plans with our Global Logistics (Commercial & Clinical), and Supply Planning business partners, which support the overall strategic plans for the Supply Chain & Quality organizations.
• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements as part of a QA team supporting Gileads global logistics operations.
• Serves as a project lead within the function or leads functional modules on large scale cross functional projects.
• Maintains routine programs and processes to ensure high quality products and compliance with EU & FDA current Good Distribution Practice (GDP) and National Association of 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, Global Supply Planning, Warehouse, Customer Service personnel as well as Trade Operations, Regulatory Affairs and Validation/Packaging Engineering.
• 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.
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