Director, External Quality Strategy and Operations 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

BS in life sciences or a relevant business area with 12+ years of varied experience
Proven track record in leading Operational Excellence (OpEx) in a Quality organization in a biotech or pharmaceutical development environment
Strong knowledge of cGMP quality systems
Expertise in leading cross-functional business and quality process mapping
Expertise in identifying improvements to existing business and quality processes
Expertise in leading OpEx initiatives that span multiple PDM External Quality teams
Ability to utilize tools & training associated with business process management in a strategic capacity
Exceptional facilitation skills to gather SME input and design clear end-to-end business and quality processes
Ability to analyze situations and/or data, applying sound judgment and reasoning, to identify and resolve problems and make recommendations
Excellent analytical, communication, and influencing skills, as well as keen problem-solving ability
Ability to evaluate options and trade-offs and utilize available resources to achieve positive business impact
Ability to partner with leaders in PDM External Quality and Global Quality to achieve business objectives

Responsibilities

Lead a team of Quality Professionals to drive strategy development and implementation of standardized communication, training, and rollout of Gilead’s Quality standards, requirements, systems, and tools to Gilead’s contract organization global network
Manage quality agreements
Coordinate quarterly management review metrics collection and annual product quality review
Define and align requirements and processes for contract organizations’ quality event management, inclusive of deviation and investigation, corrective and preventative action, and change control
Successfully and consistently roll out Gilead’s Partner Collaboration Quality System module to Gilead’s contract organization global network
Serve as key representative for Gilead’s Quality Transformation initiatives
Lead cross-functional business and quality process mapping and OpEx initiatives
Interface with members of the PDM Global Quality Leadership Team to drive meaningful process improvements in PDM Global Quality
Drive helpful changes and continuous improvements

Skills

Quality Strategy

Operations Leadership

Cross-Functional Process Mapping

Business Process Management

Operational Excellence

Quality Standards

Training Development

Contract Organization Management

Quality Agreements

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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