Director, Quality at Gilead Sciences

Foster City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Act as Designated Representative (DR) for Gilead Sciences Inc., ensuring compliance with NABP VAWD requirements and relevant regulations for Good Distribution Practice (GDP)
Maintain California Board of Pharmacy (CA BoP) Wholesale Drug Permit by meeting all licensee requirements
Serve as QA SME for DSCSA compliance and provide strategic support for operational processes
Act as Deputy Designated Representative (dDR) for Asegua, supporting compliance with state and federal laws
Coach, mentor direct reports, manage workload prioritization, monitor KPIs, and track project timelines
Perform vendor site owner responsibilities in Gilead systems for US trading partners/customers
Provide guidance on interpretation and application of US product distribution requirements
Act as PDMA Quality representative in Gilead’s Sample Compliance Committee (SCC)
Host NABP or CA BoP audits and interact closely with auditors

Responsibilities

Work with trade operations to establish and maintain a quality engagement program with US trading partners/customers
Lead/support market actions, including recalls, for Gilead products in the US market
Support shipping & distribution-related complaints process and investigations into suspect products
Manage QMS records such as deviations (internal & external), CAPAs, and Change Controls for US market distribution QA operations
Collaborate with Global QA teams, Trade Operations, Global Supply Chain, and other colleagues on US product distribution
Ensure local QA activities meet timelines, quality, and compliance expectations

Skills

Quality Assurance

GDP Compliance

VAWD Accreditation

NABP Regulations

Regulatory Compliance

Pharmaceutical Distribution

Wholesale Distribution

Compliance Management

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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