Quality Site Lead (Sr. Manager) - Foster City 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

BiopharmaceuticalsIndustries

Requirements

Experience in quality oversight of GMP activities at contract manufacturing organizations (CXOs) for biologics intermediates, drug substances, and drug products
Knowledge of pharmaceutical development, manufacturing, regulatory compliance, and standards (e.g., GMP documentation, inspections)
Ability to act as primary quality contact and key representative on Product Quality Teams
Skills in evaluating quality systems, recommending enhancements, and implementing trainings
Capability to lead escalations for critical quality issues and facilitate quality events
Strong partnership and communication skills with internal stakeholders (e.g., Global External Manufacturing, Global Supply Chain, Pharmaceutical Development, RA CMC)
Experience monitoring site trends, performance criteria, and ensuring compliance/readiness for regulatory inspections
Ability to establish Quality to Quality relationships and participate in CXO Business Review Meetings (BRMs)
Proficiency in reviewing regulatory intelligence and communicating concerns/trends/gaps

Responsibilities

Provide proactive quality oversight for assigned Gilead CXO partners/sites as primary PDM Quality contact
Assure CXOs meet Gilead’s quality, regulatory, and compliance standards for sustainable product delivery
Serve as key representative on Product Quality Teams for assigned CXO
Ensure contract manufacturers are compliant and ready for regulatory inspections; monitor progress and support onsite as needed
Facilitate quality events for CXOs
Partner with internal stakeholders to identify solutions, align on new requirements, and proactively address issues
Lead escalations for critical quality issues
Evaluate current quality systems/processes, recommend/implement enhancements and trainings to achieve long-term objectives
Monitor CXO site trends, hold accountable to performance criteria and QAG requirements
Ensure GMP documentation is accurate and compliant with standards
Provide guidance to business teams on regulatory requirements
Participate in CXO Business Review Meetings (BRMs) as Quality’s voice
Establish and foster Quality to Quality relationships between Gilead and CXOs
Conduct regular review/assessment of regulatory intelligence and communicate concerns/trends/gaps/alerts timely to Quality management

Skills

Key technologies and capabilities for this role

GMPQuality AssuranceBiologicsDrug SubstanceDrug ProductClinical ManufacturingCommercial ManufacturingRegulatory ComplianceCXO Oversight

Questions & Answers

Common questions about this position

What is the location for the Quality Site Lead position?

The position is based in Foster City, California, where Gilead Sciences is headquartered.

What is the salary or compensation for this role?

This information is not specified in the job description.

What are the main responsibilities of the Quality Site Lead?

The role involves providing quality oversight of GMP activities at assigned Gilead CXOs, ensuring compliance with quality, regulatory, and compliance standards, acting as the primary PDM Quality contact, representing on Product Quality Teams, and supporting regulatory inspections.

What is the company culture like at Gilead Sciences?

Gilead emphasizes collaboration, determination, and a relentless drive to make a difference, with people leaders driving an inclusive culture where employees feel developed and empowered. Every team member plays a critical role in scientific innovations to advance care for patients with life-threatening diseases.

What makes a strong candidate for the Quality Site Lead role?

Strong candidates will have experience in quality oversight for GMP activities at contract manufacturing organizations, expertise in ensuring regulatory compliance and inspection readiness, and the ability to partner with internal stakeholders like Global External Manufacturing and Regulatory CMC.

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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