QA Specialist III at Gilead Sciences

Mexico City, Mexico City, Mexico

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Knowledge of COFEPRIS requirements in NOM-059-SSA1
Experience with Quality Management Systems, including SOPs, samples management, returns, complaints, counterfeits, recalls, risk assessments, and change management
Ability to provide QA oversight to GxP contracted organizations (e.g., 3PLs for warehousing/distribution, CTL for testing) ensuring GMP, GDP, and GLP compliance
Expertise in documental evaluation for drug product release compliant with global standards and local regulations
Familiarity with method transfer activities for product testing
Proficiency in generating and maintaining controlled documents (e.g., Quality Manual, SOPs, WRK, methods) aligned with global standards
Skills in managing Quality Systems indicators (CAPA, Change Control, Deviations, Complaints) and escalating compliance gaps
Capability to investigate deviations, implement CAPAs, and manage local investigations
Experience with Change Control processes, including impact assessments
Ability to support training initiatives aligned with Gilead strategies
Participation in Annual Product Reviews and Quality Management Reviews (QMR)
Coordination of import permits and Quality Agreements with partners
Knowledge of data integrity and oversight at site level

Responsibilities

Support implementation of Quality Strategy for Gilead Mexico and business strategies for product distribution, testing, and release
Support and conduct Quality Management System to comply with COFEPRIS requirements, including SOPs for local activities, samples, returns, complaints, counterfeits, recalls, risk assessments, and change management
Provide QA oversight to 3PLs and CTL for documentation and compliance (GMP, GDP, GLP) for inspection readiness
Ensure efficient QA support for product warehouse, transportation, testing, and disposition
Perform documental evaluation for Drug Products release to the Mexican market
Support method transfer activities for timely testing of lots
Generate and maintain procedures and controlled documents aligned with global standards
Manage Quality Systems indicators (CAPA, Change Control, Deviations, Complaints) and escalate gaps
Investigate deviations, coordinate closures, manage local investigations, and ensure effective CAPAs
Support and manage local Change Control processes
Support internal and external training initiatives
Participate in Annual Product Review Global Reports and write local complementary reports
Support QMR process and communicate site metrics to senior management
Coordinate Import Permits with 3PL for Drug Products, Reference Standards, and Samples
Support preparation and updates of Quality Agreements with partners
Maintain data oversight at site level for full data integrity compliance

Skills

Key technologies and capabilities for this role

GMPGDPGLPGxPSOPsQuality Management SystemChange ManagementQuality Risk AssessmentProduct ComplaintsRecalls3PL OversightRegulatory ComplianceCOFEPRIS

Questions & Answers

Common questions about this position

What are the key responsibilities of the QA Specialist III role?

Key responsibilities include supporting the implementation of Quality Strategy for Gilead Mexico, conducting Quality Management System to comply with COFEPRIS requirements, providing QA oversight to GxP contracted organizations like 3PLs and CTL, ensuring QA support for product warehouse and distribution, and managing quality systems indicators like CAPA and deviations.

Is this a remote position or does it require on-site work in Mexico?

This information is not specified in the job description.

What is the salary or compensation for this QA Specialist III position?

This information is not specified in the job description.

What is the company culture like at Gilead Sciences?

Gilead emphasizes collaboration, determination, and a relentless drive to make a difference, with every employee playing a critical role in scientific innovations. They focus on great leadership, inclusion, development, and empowering employees to fulfill their aspirations.

What skills or experience make a strong candidate for this role?

Strong candidates will have expertise in Quality Management Systems, compliance with regulations like COFEPRIS NOM-059-SSA1 and GMP/GDP/GLP, experience with SOPs, CAPA, change control, deviations, product complaints, and managing QA oversight for 3PLs and testing labs.

Gilead Sciences

Develops and commercializes biopharmaceuticals

About Gilead Sciences

Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.

Foster City, CaliforniaHeadquarters

1987Year Founded

$15,873.6MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Paid family time off and paid parental time off

Generous 401(k) contribution matching

Comprehensive medical plans that cover both physical and mental healthcare

Global Wellbeing Reimbursement

Time Off

Global Volunteer Day

Giving Together Program

Employee Support Programs

Flexible Work Options

Risks

Increased competition in HIV treatment from ViiV Healthcare's expanding drug portfolio.

Regulatory scrutiny over drug pricing could impact Gilead's U.S. market operations.

Patent expirations, like Truvada's, lead to increased generic competition and revenue loss.

Differentiation

Gilead's lenacapavir is recognized as the 2024 Breakthrough of the Year for HIV care.

Partnerships with LEO Pharma and Tubulis enhance Gilead's focus on inflammatory and cancer therapies.

Gilead's commitment to health equity initiatives like COMPASS and HepConnect sets it apart.

Upsides

Gilead's strategic partnerships expand its reach in inflammatory and oncology drug markets.

Investment in digital health technologies enhances Gilead's R&D and patient engagement.

Focus on sustainability improves Gilead's operational efficiency and corporate reputation.

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