Sr Manager, Quality Assurance at Gilead Sciences

Tel Aviv-Yafo, TA, Israel

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Experience establishing and maintaining Quality Management Systems compliant with local regulatory, industry standards, and Gilead expectations
Qualification to release product batches (commercial) and perform related QP activities in compliance with local regulations and SOPs
Ability to maintain GMP and import licenses in Israel
Capability to manage local processes for change control, deviation, CAPA, and supplier management
Knowledge of GMP/GDP, including training curricula, records, CVs, and job descriptions for quality/distribution personnel
Experience managing interactions with manufacturing plants on GDP activities, new packaging, and artwork
Familiarity with Quality Management Review processes, Quality Escalation, and Annual Product Quality Reports
Skills in qualifying and managing 3PL/4PL providers, GMP/GDP suppliers/service providers, including auditing

Responsibilities

Establish and maintain the Quality Management System in Israel Affiliate to meet local regulatory, industry standards, and Gilead expectations
Release product batches (commercial) and carry out related QP activities in compliance with local regulations and relevant SOPs
Ensure strong relationships and communication with functional areas (Regulatory Affairs, Medical Affairs, Commercial, Market Access, Legal, etc.) and PDM Quality, providing updates on product quality and distribution issues
Maintain GMP and import license in Israel
Serve as contact for the MOH in Israel on quality issues
Manage local change control, deviation, CAPA, and supplier management processes
Manage interactions with the Manufacturing Plant on GDP activities, new packaging, and artwork
Manage local Quality Management Review process
Participate in Gilead’s Quality Escalation process for critical quality and regulatory compliance issues
Manage/support product out of stock situations
Ensure up-to-date organograms, training curricula for GMP/GDP, training records, CVs, and Job Descriptions for local affiliate personnel on quality/distribution matters
Establish and maintain the Affiliate Quality Manual and GMP/GDP procedural documents
Establish and maintain Quality Agreements with 3PL/4PL and local GMP/GDP suppliers/service providers
Review Annual Product Quality Reports (as applicable)
Ensure shipping conditions match product license/label and qualify transporters/transport solutions
Ensure premises/equipment are regularly reviewed for adequacy in handling, storage, and distribution of medicinal products
Support Customer Services with GDP-related enquiries (delivery issues, transportation conditions, disputes)
Work with 3PL/4PL on supply-related issues and arrange authorized relabeling/repackaging
Support management of quality and distribution complaints
Support investigation of fraudulent and counterfeit medicinal products
Manage product return and destruction
Manage local recalls and participate in supplier recall challenges or local mock recalls
Qualify and manage local 3PL/4PL and support their audits
Qualify, manage, audit, and approve local GMP/GDP suppliers/service providers

Skills

Quality Management System

GMP

QP Activities

Regulatory Compliance

Batch Release

SOPs

Regulatory Affairs

MOH

Import License

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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