Exec Director, Quality at Gilead Sciences

La Verne, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, HealthcareIndustries

Requirements

Experience over a broad set of Quality sub-functions with extensive knowledge of industry best practices and trends
Ability to quickly establish credibility with diverse audiences and be perceived as a leader
Excellent verbal, written, and interpersonal communication skills; must possess excellent influencing skills
Significant in-depth understanding of business objectives and how they translate into quality priorities
Experience and confidence necessary to work with senior executives, and the ability to build rapport with employees at all levels

Responsibilities

Develop and execute the site’s quality strategy aligned with corporate objectives and regulatory expectations
Serve as the site’s quality representative to global quality leadership and regulatory agencies
Ensure site-wide compliance with cGMP, FDA, EMA, ICH, and other applicable regulations
Lead regulatory inspections and audits, including preparation, hosting, and response management
Oversee Quality Assurance (QA), Quality Control (QC), and Compliance functions
Ensure timely release of products, materials, and batches in accordance with quality standards
Lead, mentor, and develop a high-performing quality team
Foster a culture of accountability, transparency, and continuous improvement
Serve as the final quality decision-maker for critical quality issues, deviations, and product disposition
Lead risk assessments and implement mitigation strategies
Partner with Manufacturing, Supply Chain, Technical Development to ensure quality is embedded across all site operations
Represent Quality in site leadership forums and strategic initiatives

Skills

Quality Control

Biologics

Regulatory Compliance

GMP

Continuous Improvement

Quality Management

Pharmaceutical Manufacturing

Site Quality Leadership

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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