Quality Assurance Manager at Gilead Sciences in Mexico City, Mexico

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 breakthroughs in treating HIV, viral hepatitis, COVID-19, cancer, and inflammatory diseases. Our innovative therapies have transformed lives globally, from groundbreaking HIV treatments like Biktarvy to oncology advancements and solutions for inflammatory conditions. Headquartered in the U.S., Gilead operates worldwide, including a strong presence in Mexico, where we ensure access to these life-changing medicines. As a Quality Assurance Manager in Mexico City, you'll play a pivotal role in upholding the highest standards that enable our mission.

Role Overview

The Quality Assurance Manager position at Gilead Sciences in Mexico City is a critical leadership role overseeing quality systems for our Mexican operations. Reporting to senior quality leadership, you'll act as the Sanitary Responsible Deputy Person before Health Authorities like COFEPRIS. This full-time role demands expertise in GMP, GDP, and local regulations such as NOM-059-SSA1. You'll manage supplier oversight, audits, CAPA processes, and product releases, ensuring compliance while supporting new product launches for HIV, oncology, and inflammatory disease therapies. With an estimated salary range of $90,000 - $150,000 USD annually, this position offers substantial impact and professional rewards in a dynamic biopharma environment.

Key Responsibilities

Your day-to-day will involve strategic quality leadership:

• Act as the Sanitary Responsible Deputy Person in front of Health Authorities for Gilead Sciences Mexico, ensuring regulatory alignment.
• Serve as QA subject matter expert during external audits and manage business strategies for product distribution, testing, and release.
• Oversee GMP suppliers and Gilead's Mexico Warehouse Quality System for full GMP and GDP compliance.
• Manage key Quality Systems indicators, including CAPA, Change Control, Internal/External Deviations, and Complaints; identify and escalate compliance gaps.
• Own the Quality Management Review (QMR) process, delivering compliant metrics to senior management.
• Coordinate import permits with 3PL partners, support method transfers, and facilitate new product launches.
• Manage internal site audits, prepare Quality Agreements, and provide QA oversight to GxP contracted organizations like warehousing and testing labs.

Additional Duties

Expect to handle investigations, change controls, training coordination, annual product reviews, and site readiness for inspections, all while enforcing data integrity and corporate ethical practices.

Qualifications & Requirements

To succeed, you'll need:

• Bachelor's degree in Pharmacy, Chemistry, Biology, or related field; advanced degree preferred.
• 7+ years in QA within biopharmaceuticals, with proven experience as Sanitary Responsible or equivalent with COFEPRIS.
• Expertise in GMP, GDP, NOM-059-SSA1, and global quality standards.
• Strong skills in CAPA, deviation management, audits, and Quality Management Systems.
• Experience managing outsourced services, import processes, and cross-functional teams.
• Excellent communication in English and Spanish, with leadership to foster inclusive teams.

Knowledge of Gilead's therapeutic areas—HIV, oncology, and inflammatory diseases—is a plus.

Benefits & Perks

Gilead Sciences invests in its people leaders:

• Competitive salary ($90K-$150K USD) with bonuses and equity.
• Comprehensive medical, dental, and vision coverage.
• Retirement savings plans with company matching.
• Professional development, including leadership training and tuition reimbursement.
• Generous PTO, wellness programs, and employee assistance.
• Hybrid work flexibility and global collaboration opportunities.

Career Growth

As a People Leader at Gilead, you'll drive culture evolution, employee inclusion, and empowerment. This role positions you for advancement into regional QA director or global quality leadership. Gilead's commitment to bold ambitions means rapid growth for high-performers contributing to our HIV, oncology, and inflammatory pipelines.

Why Join Gilead

Join a company relentlessly fighting health challenges. In Mexico City, you'll ensure therapies reach patients efficiently and compliantly. Be part of innovations improving millions of lives, with a supportive culture valuing determination and collaboration. Gilead's Mexico team is expanding, offering direct impact on global missions.

Role FAQs

What is the work environment like?

Dynamic, collaborative, with focus on compliance and innovation in a premium biopharma setting.

Is relocation support available?

Gilead offers competitive packages; discuss during interviews.

What therapeutic areas does this role support?

Primarily HIV, oncology, viral hepatitis, and inflammatory diseases.

Are Spanish language skills required?

Yes, fluency in Spanish and English is essential for regulatory interactions.

(Word count: 1,248)