For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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

Role Purpose:

Quality Assurance Specialist III will work collaboratively with relevant stakeholders to implement & maintain the local QMS and will work with internal & external stakeholders to ensure quality requirements are met for Gilead products, throughout the distribution network, and within S. Korea, all the way to patients.

Key Responsibilities:

• Ensure the QA import process to fulfills all requirements according to KGIP (Korea Good Importing Practice) and relevant regulations.

• Provide a quality oversight of product incoming inspection and packaging component inspection.

• Liaise with Suppliers and Distribution team any issue during shipment (e.g. damaged goods) and support to resolve this issue.

• Review the temp. monitoring data of product shipment and raise any issue to Suppliers.

• Ensures shipping conditions match the product license/product label particulars and transporters are appropriately qualified.

• Ensure the retain samples is stored and maintained at 3PL warehouse.

• Operates and maintains the Quality Management System in S. Korea to ensure that it meets local regulatory and industry standards and Gilead expectations.

• Handles the product quality complaint including intaking in the system, reporting to Central team, collection and shipping samples, following up an investigation, communication with Central team, 3PL (distributor), and reporter.

• Open a change control, deviation, CAPA in the system as an owner or investigator.

• Supports a local supplier/service provider’s management in conjunction with corporate process.

• Manages quality related procedural documents (e.g., Quality Manual, SOP) and records.

• Perform a country level annual quality review, manufacturing sites' status, and stability program based on global review to fulfill local requirements.

• Maintains local product master files up-to-date with regulatory filings.

• Supports affiliate's Self-Inspection and Quality Management Review.

• Supports local recalls and participating in supplier’s recall challenge or perform local mock recall, as needed.

• Supports to training curricula pertaining to GMP/GDP, training records, CVs, and Job Descriptions are in place for local affiliate personnel working on quality/distribution matters.

• Has a role of Quality point of contact to 3PL warehouse and external testing lab.

• Support the use of quality document management system with 3PL warehouse and external testing lab.

• Track the external events which 3PL warehouse and testing laboratory provided (e.g. deviation, change notification, and etc.).

• Request the local release testing to an external testing laboratory.

• Liaise with corporate analytical team to supply the in-house material to an external testing laboratory and facilitate the material importation.

• Working with 3PL, provides guidance on supply related issues.

• Assure customers validations and adequate records compliance to Gilead QA requirements are established and maintained for all local distributors/customers.

• Support maintenance of relevant licenses.

• Collaborates with RA to support inspections and audits.

• Collaborates with RA to implement activities for new product launch and product life cycle management.

• Supports audit of distributor (where applicable).

Knowledge, Experience & Skills:

• Highly organized individual with a strong work ethic and ability to work flexibility and independently.

• Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Distribution Practices (GDPs)

• Demonstrate thorough knowledge of MFDS GMP/GDP requirements/standards and the interface with other functions like 3PL warehouse and testing laboratory.

• Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.

• Demonstrates proficiency in Quality Systems processes (Deviation, CAPA, Change Control, Complaints, etc.)

• Demonstrates a knowledge of regional/local regulatory requirements and industry standards.

• Demonstrates basic verbal, written, and interpersonal skills in English.

• Demonstrates proficiency in Microsoft Office applications, particularly, WORD, Excel, PowerPoint, and Teams. Familiarity with technology platforms such as Veeva Vault, SAP ERP, etc.

• Working knowledge of Risk Management tools (e.g., Failure Mode Effects Analysis (FMEA) is preferred.

Typical Educational Experience & Competencies

• Degree in Pharmacy (a Korea Pharmacist License) preferred.

• Bachelors’ degree and 6 years of relevant experience in a GMP or GDP environment-related field

• Masters’ degree and 4 years of relevant experience in a GMP or GDP environment related field.

• Ability to work on own initiative as well as display strong teamwork skills.

• Demonstrates clear personal responsibility for own work, in terms of both the quality of the work and the manner in which it is performed. ‘

• Ability to support change and respond to change requirements by continually striving to improve working processes and systems, consistent with the organizational strategy.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.