Sr Specialist, Quality Systems at Gilead Sciences

Parsippany, New Jersey, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs)
Demonstrates proficiency in application of QA systems principles, concepts, industry practices, and standards, particularly related to change management
Demonstrates ability to effectively manage multiple complex projects and priorities simultaneously
Demonstrates ability to work independently
Has proven analytical and conceptual skills
Demonstrates understanding of international quality standards (inferred from context)

Responsibilities

Independently and proactively initiate and drive the planning, execution, and completion of change management projects
Develop and implement strategies to mitigate risks within the change management process and change control system
Facilitate and present at cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance to QMS and regulatory expectations
Manage change controls related to manufacturing product, process, equipment, facility, and computerized systems contributing to the oversight of key strategic, tactical, and operational goals
Develop, deliver, and improve the change management program for various levels of the organization, while also ensuring training effectiveness
Independently review, initiate, complete, and thoroughly document critical, major, and minor change controls, managing local and global change controls and associated activities related to GxP operations
Navigate through complex change review discussions, facilitating to a common decision for each change regarding approach and follow-up actions to be taken, and documenting the decisions and evaluations accordingly
Support management and monitoring of change records for adherence to organizational or departmental metric targets, and maintenance of associated tracking tools/databases
Support management review process through development and generation of quality system metrics and trending, and escalate issues as required
Work closely with Change Management Business Process Lead and business support team members to support enhancements of the change control QMS processes and business process
Support the maintenance and improvement of quality systems processes, as needed
Work directly with operating entities and internal clients to ensure follow-up of change tasks
Participate in compliance audits as required
Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs)
Write and/or implement changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed
Provide guidance and technical knowledge to more junior staff, and monitor the performance of daily tasks

Skills

Key technologies and capabilities for this role

Change ManagementRisk MitigationChange ControlQuality Management SystemRegulatory ComplianceCross-Functional MeetingsTraining EffectivenessManufacturing ProcessesEquipment ManagementComputerized SystemsStakeholder Alignment

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Is this role remote or does it require office presence?

This information is not specified in the job description.

What key skills are required for the Sr Specialist, Quality Systems role?

The role requires strong change management expertise, risk mitigation strategies, cross-functional facilitation, thorough documentation skills, and knowledge of QMS and regulatory compliance.

What is the company culture like at Gilead Sciences?

Gilead emphasizes collaboration, determination, and a relentless drive to make a difference, with a focus on employee development, inclusion, empowerment, and strong people leadership.

What makes a strong candidate for this Quality Systems Specialist role?

Strong candidates will have the ability to independently drive change management projects, facilitate complex cross-functional discussions, ensure QMS and regulatory compliance, and support process improvements.

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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