About Gilead Sciences

Gilead Sciences is a leading biopharmaceutical company dedicated to creating a healthier world for all people. For over 35 years, Gilead has pioneered therapies for some of the world's most challenging diseases, including HIV, viral hepatitis, COVID-19, and cancer. With a relentless focus on innovation, Gilead develops life-changing treatments that improve patient outcomes and ensure global access to cutting-edge medicines. The company's work extends to oncology and inflammatory diseases, where breakthrough therapies are transforming lives. Headquartered in the U.S., Gilead operates worldwide, including a strong presence in Asia-Pacific, fostering collaboration, determination, and scientific excellence.

Role Overview

As Sr Manager, Quality Assurance at Gilead Sciences in Seoul, South Korea, you will play a pivotal role in ensuring the highest standards of quality for cell therapy products, particularly in apheresis and treatment centers (ACTS). This leadership position involves establishing qualification processes, managing compliance with local regulations like KFDA, and collaborating across global teams. Reporting to quality leadership, you will serve as the Responsible Person (RP) for South Korea, overseeing distribution, investigations, and regulatory readiness. This full-time role offers the chance to lead industry-best practices in a dynamic biopharma environment focused on Kite cell therapies.

Key Impact Areas

Your expertise will drive the maturation of site qualification programs, sustain compliance amid regulatory changes, and enhance patient traceability through validated systems. With Gilead's bold ambitions in HIV treatments, oncology advancements, and inflammatory disease solutions, your contributions will directly support global health initiatives.

Key Responsibilities

In this senior role, you will:

• Establish, execute, and manage qualification processes for new and established apheresis centers and treatment sites (ACTS) using risk-based tools for qualification, training, and monitoring.
• Collaborate with Global Site Qualification teams to strategize program maturity, sustainability, and adaptation to regulatory changes.
• Provide leadership in site qualification and management, working cross-functionally with Commercial, Supply Chain, and Kite T cell Facilities.
• Assess and approve changes to courier tracking and order intake systems to maintain validated states.
• Implement metrics monitoring, reporting, and updates for approved ATC lists, ensuring patient traceability.
• Act as Quality contact for ATCS issues, leading investigations and resolutions.
• Support inspection readiness and interact with regulatory agencies on ATCS matters.
• Serve as Gilead RP per KFDA guidelines, with backup responsibilities in other APAC regions, including Australia and Singapore.
• Oversee QMS elements like GDP distribution, product complaints, recalls, and self-inspections.
• Provide QA oversight for deviations, change controls, and Material Review Board for cell therapy products.

Qualifications & Requirements

To succeed in this role, candidates must demonstrate:

• A Bachelor’s degree in medical or biological sciences, or related field; Master’s or PhD preferred.
• Minimum 7 years of progressive experience in quality assurance within medical, pharmaceutical, or biologics sectors, with preference for cell therapy.
• Experience in clinical research, medical liaison, cell therapy, apheresis centers, or auditing blood banks/plasma centers/external suppliers.
• Strong knowledge of GMP conformance to South Korea (KFDA) regulations and experience responding to agency audits.
• Proficiency in English and Korean, with excellent interpersonal, verbal, and written communication skills.
• Demonstrated ability to develop, coach, and mentor teams in multi-national settings.

Preferred Expertise

Ideal candidates bring experience in multi-regional staff management and a passion for Gilead's mission in HIV, oncology, and inflammatory diseases.

Benefits & Perks

Gilead Sciences offers a premium compensation package tailored to attract top talent:

• Competitive base salary estimated at $90,000 - $150,000 USD annually, adjusted for South Korea market with performance bonuses.
• Comprehensive health insurance, including medical, dental, and vision coverage.
• Retirement savings plans with company matching.
• Generous paid time off, parental leave, and flexible working arrangements.
• Professional development programs, tuition reimbursement, and leadership training.
• Employee wellness initiatives, including fitness subsidies and mental health support.
• Stock purchase plans and long-term incentive opportunities.

Career Growth

At Gilead, every employee is empowered for growth. As a People Leader, you will drive cultural evolution, fostering inclusion and development. This Sr Manager role positions you for advancement into director-level Quality or Regulatory positions within APAC or globally. Gilead invests in mentoring, cross-functional projects, and exposure to innovative pipelines in HIV therapies, oncology, and inflammatory diseases, ensuring your career aligns with ambitious goals.

Why Join Gilead

Joining Gilead means contributing to therapies that combat HIV, advance oncology treatments, and address inflammatory diseases, making a tangible difference in patients' lives. In Seoul, you will collaborate with global experts, leverage cutting-edge cell therapy technologies, and thrive in an environment that values innovation, compliance, and people leadership. Gilead's commitment to bold ambitions creates opportunities for direct impact, professional fulfillment, and a supportive culture where every voice matters.

Role FAQs

Q: What is the employment type? A: This is a full-time, permanent position.

Q: Is Korean language proficiency required? A: Yes, proficiency in both English and Korean is essential for regulatory and local interactions.

Q: What experience level is needed? A: Minimum 7 years in QA, preferably in cell therapy or biologics.

Q: Does the role involve travel? A: Yes, collaboration with APAC regions, Australia, Singapore, and Kite facilities may require travel.

Q: How does this role support Gilead's mission? A: By ensuring quality compliance for cell therapies, enabling access to innovative treatments for HIV, cancer, and beyond.

Q: What are the next career steps? A: Opportunities for promotion to senior leadership in Quality Assurance or Regulatory Affairs.