Assoc Director, R&D Quality 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

Biotechnology, PharmaceuticalsIndustries

Requirements

Ability to work with little to no immediate supervision
Expertise in evaluating new tools as fit for purpose
Experience coordinating and reviewing the work of others
Skills in managing and/or leading audits or projects involving multiple sites or therapeutic areas
Ability to direct others in the oversight of activities performed by contract auditors
Capability to establish relationships and agreements with contract auditors
Proficiency in evaluating departmental and business area SOPs for fit for purpose and regulatory compliance
Knowledge to ensure adherence to departmental standards across sites
Experience leading intra- or interdepartmental teams for operational purposes (e.g., regulatory changes, continuous improvement)
Ability to assist in readiness for and coordination of responses to regulatory agency inspections
Skills in developing and presenting training using standard modules and on special topics
Capability to ensure appropriate content of training modules
Ability to initiate operational change and communicate it positively
Strong planning skills, considering multiple factors, anticipating work, and prioritizing to meet tight timelines
Experience directing others in prioritizing their work
Ability to define systems or processes to ensure high compliance standards
Skills in checking perspectives of others and adapting communication approaches
Ability to build positive support for positions outside formal meetings
Proficiency in determining efficient and appropriate communication methods in various situations
Understanding of the impact of actions/decisions (incomplete in JD but implied)

Responsibilities

Foster a commitment to quality in individuals and a culture of quality within the organization
Manage and/or lead various types of audits or projects involving multiple sites or therapeutic areas (area limited to Clinical Compliance, Laboratory Compliance, or Electronic Systems Compliance)
Direct others in the oversight of activities performed by contract auditors
Establish relationships and agreements with contract auditors
Evaluate departmental and business area SOPs for fit for purpose and compliance with regulatory requirements
Ensure adherence to departmental standards across sites
Lead intra- or interdepartmental teams of an operational nature (e.g., preparing for minor regulatory changes, continuous improvement initiatives) for input and information dissemination
Assist in readiness for regulatory agency inspections and coordinate responses to findings
Develop and present training using standard modules and on special topics
Ensure appropriate content of training modules
Initiate operational change where required and communicate it positively
Plan, anticipate, and prioritize work to meet tight timelines, directing others in prioritization
Define systems or processes to consistently ensure high compliance standards

Skills

Quality Assurance

R&D Quality

Regulatory Compliance

Leadership

Team Development

Pharmaceutical Quality

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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