Specialist / Manager, QA - Kite at Gilead Sciences

Tokyo, Japan

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, BiotechnologyIndustries

Requirements

Bachelor’s degree in medicine, dentistry, pharmacy, veterinary medicine, or biology (or related field)

Responsibilities

Responsible for market release of Cell Therapy Finished Products in Japan and quality monitoring of importation of Cell Therapy Finished Products in Japan
Maintain and update local QMS/GQP to adhere to local regulation (e.g., PMDA)
Provide QA oversight and approve deviations, change controls, and product complaints investigations for the manufacture, packaging, and shipping events impacting Cell Therapy Products for Japan when applicable
Provide information, guidance, or reports to management when specific compliance issues arise
Oversee and interface with Japan CMO to address and resolve performance issues and quality events
Maintain metrics related to Quality of Commercial Cell Therapy Product(s)
Act as Japan lead or support for Japan health authorities (PMDA, etc.) inspections, product complaints, deviations, or recall/Field Corrective Actions (reporting to Japan health authorities (PMDA, etc.))
Responsible for tracking and reporting metrics
Support inspection readiness plans and interact with regulatory agencies during inspections on Kite related matters
Lead for affiliate Kite GMP self-inspections
Conduct and manage internal or external audits
Work with Regional and Corporate (Quality) teams, as needed
Collaborate cross-functionally with the Japan Gilead affiliate to fulfill all responsibilities as MAH
Perform other duties as assigned

Skills

Key technologies and capabilities for this role

Quality AssuranceQACell TherapyCARTCRImmunotherapyBiopharmaceutical

Questions & Answers

Common questions about this position

What is the salary for this QA Specialist/Manager position at Kite?

This information is not specified in the job description.

Is this QA role remote or based in a specific location?

This position will be in Japan.

What are the key responsibilities for this QA role in Japan?

Responsibilities include market release of Cell Therapy Finished Products in Japan, quality monitoring of importation, maintaining local QMS/GQP to adhere to regulations like PMDA, and providing QA oversight for deviations, change controls, and product complaints.

What is the company culture like at Gilead and Kite?

Gilead emphasizes collaboration, determination, and a relentless drive to make a difference, with people leaders key to evolving culture and creating an inclusive environment where employees feel developed and empowered.

What makes a strong candidate for this QA Manager/Sr. Specialist role?

A highly motivated individual with expertise in Quality Assurance, experience in Good Quality Practice (GQP), and ability to work cross-functionally in cancer immunotherapy commercial operations in Japan.

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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