Senior Director — Quality Assurance Head, Small Molecules 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

PhD/PharmD with 12+ years of experience OR MS with 12+ years of experience OR BS with 14+ years of experience
Preferred: 12+ years’ experience in Biopharmaceutical or Pharmaceutical manufacturing quality assurance and quality control

Responsibilities

Demonstrate ownership of a site Pharmaceutical Quality System (PQS) aligned to the Quality Manual, including policy/standards oversight, CAPA/change control governance, data integrity, risk-based approaches, and periodic management reviews
Run an independent QA function with authority for final batch disposition, QA oversight of manufacturing/testing, and independence from production per GMP Quality Manuals
Ensure hands-on leadership for QA responsibilities including complaints handling, investigations, escalation of serious GMP issues, internal audits/self-inspection, and training effectiveness
Lead batch release decisioning (jurisdiction control, cross input integration), leveraging digital tools and analytics per Quality digital roadmaps
Ensure site-wide compliance with cGMP, FDA, EMA, ICH, and other applicable regulations
Represent the company to health authorities and navigate challenging audit situations
Oversee Quality Assurance (QA) and Compliance functions
Ensure timely release of products, materials, and batches in accordance with quality standards
Champion continuous improvement to reduce deviations and cycle times, improve CAPA effectiveness, and enhance audit readiness
Identify and manage quality risks across the product lifecycle and implement mitigation strategies
Act as an escalation point for complex/high impact quality issues and decisions
Lead, mentor, and develop a high-performing quality team
Foster a culture of accountability, transparency, and continuous improvement
Build high-performing QA teams and partner closely with QC to ensure technical rigor and compliance (clear QA vs. QC accountability split)
Represent Quality Assurance in site leadership forums and strategic initiatives
Partner with Site and global Quality leaders to assure supply and compliance

Skills

Quality Assurance

Pharmaceutical Quality System

PQS

GMP

CAPA

Change Control

Data Integrity

Risk-Based Approaches

Batch Disposition

Inspection Management

Continuous Improvement

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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