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, the company develops life-changing treatments that improve lives and ensure global access to cutting-edge medicines. Gilead's work extends to oncology and inflammatory diseases, where breakthrough therapies are transforming patient outcomes. Headquartered in the U.S., Gilead maintains a strong presence in Europe, including its state-of-the-art facility in Cork, Ireland, a hub for manufacturing and quality excellence.

Role Overview

The Qualified Person (QP) role at Gilead Sciences in Cork, Ireland, is pivotal in upholding the highest standards of pharmaceutical quality and regulatory compliance. As a QP, you will certify batches for sale or supply, ensuring they meet stringent EU regulations. This position demands a deep understanding of Good Manufacturing Practices (GMP) and quality assurance principles, making it ideal for seasoned professionals passionate about biopharmaceutical excellence. Reporting into quality leadership, you will collaborate across manufacturing, QC, and regulatory teams to drive product integrity from production to market.

Why This Role Matters

In the fast-paced biopharma sector, the QP serves as the final gatekeeper for product release, directly impacting patient safety and Gilead's reputation for quality. Your expertise will support Gilead's portfolio in HIV treatments like Biktarvy, oncology innovations, and therapies for inflammatory conditions, contributing to global health advancements.

Key Responsibilities

The Qualified Person at Gilead Sciences undertakes a broad range of critical duties to maintain compliance and quality:

• Comply with EC directives as the responsible QP, certifying batches for sale or supply.
• Approve Annual Product Quality Reviews, SOPs, complaint investigations, and deviations via EQMS.
• Participate in Event Review, Quality Systems Review, and Site QP Meetings.
• Review manufacturing, environmental monitoring, and quality control data for in-process and finished products.
• Work with operating entities on inspections, audits, statistical process control, and CAPA recommendations.
• Interface with regulatory agencies and contract manufacturers to resolve documentation issues.
• Contribute to controlled documents, training programs, and new product start-ups.

Qualifications & Requirements

To excel as a Qualified Person at Gilead, candidates must meet rigorous standards:

• Minimum education and experience per Directive 2001/83/EC for medicinal products for human use.
• BS/BA or MS in a relevant scientific discipline, with extensive pharmaceutical industry experience.
• Proficiency in GMP/GLP, QA principles, and international quality systems.
• Strong analytical skills, project management, and knowledge of Six Sigma DMAIC, FMEA, or HACCP beneficial.
• Excellent verbal, technical writing, and interpersonal skills; proficient in Microsoft Office.

Preferred Experience

Ideal candidates bring proven expertise in batch release, deviation management, and regulatory interactions within biopharma manufacturing.

Benefits & Perks

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

• Competitive salary estimated at €90,000–€150,000 annually, based on biopharma sector rates in Cork with a 5-10% buffer.
• Comprehensive health insurance, pension contributions, and family benefits.
• Generous paid time off, flexible working arrangements, and wellness programs.
• Access to cutting-edge facilities in Cork, supporting work-life balance.
• EEO policy ensuring non-discriminatory practices across all employment aspects.

Career Growth

Gilead invests in employee development, positioning QPs for advancement into senior quality leadership or regulatory affairs roles. Through targeted training, mentorship, and exposure to global projects, you will build expertise in emerging therapies for HIV, oncology, and inflammatory diseases. People Leaders at Gilead foster inclusive environments, empowering your professional aspirations.

Why Join Gilead

Joining Gilead means becoming part of a mission-driven team tackling humanity's biggest health challenges. In Cork, Ireland, you will work in a collaborative, innovative setting with access to world-class resources. Gilead's commitment to bold ambitions ensures direct impact on patients worldwide, from advancing HIV cures to oncology breakthroughs and inflammatory disease solutions. With a culture of inclusion, development, and empowerment, every employee is a cornerstone of success.

Role FAQs

What are the QP certification requirements?

Candidates must fulfill EC Directive 2001/83/EC criteria, including relevant education and pharmaceutical experience.

Is relocation support available?

Gilead offers competitive packages; inquire during application for Cork-specific details.

What diseases does Gilead target?

Key areas include HIV, oncology, viral hepatitis, COVID-19, and inflammatory diseases.

How does Gilead support career progression?

Through leadership development, training, and global opportunities in quality and beyond.

Is this a full-time role?

Yes, full-time position at the Cork, Ireland site.