Product Quality Lead 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

Biotechnology, PharmaceuticalsIndustries

Requirements

Scientific and technical understanding of drug development and commercialization
Expert in analytical control systems, with proactive lifecycle management, technical leadership, and ownership
Deep understanding of analytical methods (development, validation, transfer, and monitoring) and product aspects (process development, CQA analysis, stability, comparability)
Ability to evaluate global product filing strategies with core PDM Team for implementation
Ability to provide timely support for health authority interactions, including authorship/review of relevant information requests for in-process controls, process development (comparability), method validation, specifications, reference standards, and stability
Ability to build internal knowledge and capabilities on product control strategies and proactively share expertise

Responsibilities

Establish phase-appropriate product specifications for Gilead’s clinical and commercial products
Develop end-to-end product quality strategy and serve as the QA main point of contact on the PDM Product Strategy Team(s)
Provide effective quality oversight and feedback for assigned program(s) by liaising between Product Strategy Team, Manufacturing, Analytical functions, Supply Chain, RA CMC, and wider PDM Quality organization
Assure network-wide harmonization of analytical control systems
Provide technical oversight of product specification setting and justification based on scientific approach
Provide timely support for health authority interactions on the product, including authorship/review of relevant health authority information requests
Build internal knowledge and capabilities on product control strategies and proactively share expertise with other functional groups
Accountable for end-to-end quality compliance of the assigned product/program, including strategic leadership, direction for quality/compliance activities, and ownership of the overall product risk log
Serve as the primary Quality representative in PDM meetings
Lead Product Quality Teams (PQT) supporting the product/program, ensuring visibility and communication of strategy, key project timelines, and CMC milestones
Monitor and review cross-functional process and product data to identify trends, ensure significant quality/compliance risks are identified, mitigated, and escalated timely
Review and approve strategy for change controls impacting the product/program lifecycle
Provide technical oversight of Major/Critical Deviations, CAPAs, Biological Product Deviations, and Complaints
Contribute to review of regulatory submissions (IND, IMPD, BLA, NDA, MAA) and assist with regulatory communications (e.g., responses to agency information requests, Notified Body Option)
Provide oversight for changes to drug substance/product

Skills

analytical control systems

drug development

commercialization

CMC

supply chain

lifecycle management

product specifications

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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