Manager, 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.

Job Description
 

The Manager, Quality Assurance - Distribution (US market), a member of the Global Product Distribution & Affiliates (GPD&A) group, supports distribution of Gilead products (including prescription samples)  within the US market. This role acts as Designated Representative (DR) for Asegua Therapeutics LLC’s (Asegua), a wholly owned subsidiary of Gilead Sciences Inc, and works closely with the Director QA as well as with internal & external stakeholders, to ensure quality requirements are met and compliance to Good Distribution Practice (GDP) is adhered to for Gilead products, throughout the US distribution network to patients.

Key Responsibilities:

• Act as Designated Representative (DR), for Asegua, responsible for ensuring compliance with National Association or Boards of Pharmacies (NABP) Verified-Accredited Wholesale Distributors (VAWD) requirements as well as all relevant regulations pertaining to current best practice

• Responsible for maintaining the Californian Board of Pharmacy Wholesale Drug Permit (license) by ensuring all licensee requirements are met

• Manage medical samples process for Gilead products in the US market and ensure compliance with the Prescription Drug Marketing Act (PDMA) 

• Support the engagement program for quality with Gilead’s US trading partners/customers

• Support operational activities relating to implementation of the Drug Supply Chain Security Act (DSCSA) requirements, as required

• Act as Deputy Designated Representative (dDR) for Gilead Sciences Inc., supporting the DR to ensure compliance with state pharmacy state and federal laws and regulations pertaining to current best practice

• Support market actions, including recall, of Gilead/Asegua products distributed in US market

• Support Complaints process for US market and investigations into suspect product, as required.

• Generate, review and/or approve QMS records such as deviations (internal & external), CAPAs & Change Controls related to QA Operations supporting US market

• Support implementation of existing and new US requirements & guidelines pertaining to product distribution in Gilead’s processes & procedures

• Collaborate with Global QA teams as well as working cross-functionally with Trade Operations personnel and other relevant colleagues supporting all aspects of US product distribution

• Host/Support NAPB audits of Asegua as well as supporting external FDA audits and internal audit programs, as required

• Generate & maintain Standard Operating Procedures (SOPs) and other types of documentation to ensure quality objectives are met

• Deliver training to colleagues in processes & procedures relevant to GDP compliance as it relates to activities covering US market

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

• Participate in local and corporate projects and process improvement initiatives, as required.

Knowledge, Experience & Behaviors:

• 7+ years of relevant experience in the pharmaceutical industry and a BS or BA (a pharmacy degree or equivalent an advantage).

• Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment.

• Experience in US market to include supporting FDA inspections.

• Demonstrates proficiency in Good Distribution Practices (GDP), and Drug Supply Chain Security Act (DSCSA) and and Prescri