Sr Quality Engineer I at Gilead Sciences

Foster City, California, United States

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Medical DevicesIndustries

Requirements

Bachelor’s degree in science or engineering-related field with at least 6 years of experience in the medical device industry, OR Master’s degree with at least 4 years of relevant experience
In-depth knowledge of Quality principles, concepts, industry practices, and standards
Quality experience in both clinical and commercial products
Strong understanding of U.S. and international quality systems regulations/standards
Ability to work independently and in a global team environment
Excellent interpersonal and communication skills
Preferred Qualifications
Previous experience with combination devices (e.g., autoinjectors, pre-filled syringes)
Well-versed in risk management methodologies and tools (e.g., Hazard Analysis, FMEA)
Knowledge of ISO 14971 Risk Management processes
ASQ certifications (Certified Quality Auditor, Certified Quality Engineer, Certified Quality Manager) or equivalent

Responsibilities

Develop key relationships and interface extensively with internal stakeholders to address and resolve quality and compliance issues related to drug-device combination products
Identify gaps in existing processes and lead cross-functional teams to develop and implement solutions
Write and/or implement changes to controlled documents (e.g., SOPs, Specifications, Work Instructions)
Work with management and department personnel to achieve goals and strategic initiatives
Identify, plan, and execute changes to quality processes to ensure conformance and continuous improvement
Ensure changes to commercial products comply with FDA QSR/QMSR, ISO 13485, and other applicable standards
Maintain compliance with global Risk Management processes in accordance with ISO 14971 and other applicable standards
Collaborate with SMEs from R&D, Clinical, and Operations to ensure comprehensive application of risk processes
Participate in annual product reviews and periodic updates of DHF and RMF
Maintain expertise in current and emerging requirements and quality trends for Pharmaceuticals, Medical Devices, and Combination Products worldwide
Support due diligence and internal/external audits or inspections as needed
Assist with complaint investigations and communicate findings to design, development teams, and CMOs
Stay abreast of evolving regulatory requirements to ensure compliance of commercial products
May support design and development activities as required

Skills

Key technologies and capabilities for this role

Quality EngineeringCombination ProductsDrug-DeviceSOPsSpecificationsProcess ComplianceCross-Functional TeamsLifecycle ManagementPre-filled SyringesAutoinjectors

Questions & Answers

Common questions about this position

What are the key responsibilities of the Sr Quality Engineer I role?

The role involves developing relationships with stakeholders to resolve quality issues for drug-device combination products, identifying process gaps and leading solutions, writing changes to controlled documents, ensuring compliance with FDA QSR/QMSR, ISO 13485, and ISO 14971, and supporting audits and complaint investigations.

What skills or expertise are required for this position?

Expertise in FDA QSR/QMSR, ISO 13485, ISO 14971, quality processes for pharmaceuticals, medical devices, and combination products is required, along with skills in risk management, controlled document management, cross-functional collaboration, and staying current on regulatory trends.

What is the work arrangement or location for this role?

This information is not specified in the job description.

What is the salary or compensation for this position?

This information is not specified in the job description.

What does Gilead's company culture emphasize?

Gilead emphasizes collaboration, determination, a relentless drive to make a difference, inclusion, development, empowerment of employees, and strong people leadership to evolve the culture.

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.

Land your dream remote job 3x faster with AI

Try Jobo Free