Assoc Director, Quality Assurance (Global Supplier 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

Pharmaceuticals, BiotechnologyIndustries

Requirements

BA/BS degree and 10+ years of relevant experience; OR MA/MS degree and 8+ years of relevant experience; OR PhD/PharmD and 5+ years of relevant experience
Degree in science or engineering with relevant GMP experience
Demonstrated leadership in managing external suppliers in a regulated environment
At least 4+ years of experience overseeing CDMOs or suppliers
(Preferred) Deep understanding of biologics manufacturing and raw material categories (e.g., SUS, filtration, extractables/leachables)
(Preferred) Experience with Quality Management Systems, regulatory inspections, and supplier audits
(Preferred) Strong cross-functional collaboration skills with experience influencing at multiple organizational levels
(Preferred) Strong understanding of incoming material inspection processes, including sampling strategies

Responsibilities

Provide strategic quality leadership for biologics material suppliers across internal and external manufacturing networks
Lead supplier investigations, deviations, and CAPAs, ensuring timely resolution and systemic improvements
Oversee supplier-initiated changes and global change notifications, including impact assessments and cross-functional implementation
Drive supplier selection, onboarding, and lifecycle management in collaboration with Quality, Supply Chain, Technical Development, Manufacturing Operations
Lead negotiation and governance of Quality Agreements with key suppliers and internal partners
Monitor supplier performance, risk indicators, and compliance trends; present insights to senior leadership
Ensure data integrity and alignment of supplier master data in SAP and related systems
Oversee and ensure timely, high-quality responses to audit observations, collaborating with internal and external stakeholders to drive sustainable remediation and readiness
Apply quality risk management principles across materials and supplier decisions
Lead or support cross-functional initiatives to optimize raw material and supplier lifecycle management, with a focus on risk mitigation, compliance, and continuous improvement
May manage and mentor team members depending on organizational needs
Travel may be required up to 20%

Skills

Supplier Quality

Quality Assurance

Biologics

Risk Mitigation

Lifecycle Management

Supplier Investigations

Deviations

External Manufacturing

Cross-functional Leadership

Stakeholder Management

Single-use Systems

Resins

Filters

Media

Excipients

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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