Mgr, Quality Assurance at Vontive

Minato-ku, 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

Healthcare, Medical Devices, PharmaceuticalsIndustries

Requirements

Specialized knowledge of GQP and QMS regulations
Ability to act as Hinseki Quality manager and GQP Quality Assurance Manager under pharma/MD MAH requirements

Responsibilities

Assist department and divisional head with overall product quality tasks, including quality agreements with domestic and overseas manufacturers, and perform GMP management
Serve as GQP Quality Assurance Manager for system operation, maintenance, and duties including shipping management, factory audits, change management, deviation processing, complaint processing, recall processing, self-inspection, education/training, and revision of quality documents/procedures
Manage documents related to GQP ministerial ordinances and GDP guidelines, including SOP creation and revision
Create, revise, or supervise the “Product Master Formula” as a GQP document
Manage QMS-related records such as change/deviation management, education/training, and self-inspection
Support creation of annual product reviews, management reviews, and KPI reports
Manage GMP manufacturing facilities for domestic and overseas manufacturers in cooperation with CMO management
Execute or supervise other quality assurance-related work
Participate in new product introduction/manufacturing site transfer projects, including regulatory compliance, application/approval support, and quality assurance system construction
Support departmental management for budget and personnel
Manage members and tasks in own group efficiently
With PS group, handle intake, data, review, and processing of quality information (complaints from medical institutions) domestically and overseas, including document exchange for records
Communicate and cooperate with domestic and international stakeholders in other departments
Assist department manager in establishing and maintaining QMS by concluding and revising quality agreements with manufacturers

Skills

Key technologies and capabilities for this role

GQPQMSGMPQuality AssuranceMedical DevicesPharmaceuticalsFactory AuditChange ManagementDeviation ProcessingComplaint ProcessingRecall ProcessingSelf-InspectionQuality Policy

Questions & Answers

Common questions about this position

What is the employment type for this Quality Assurance Manager role?

This is a full-time position.

What salary or compensation is offered for this position?

This information is not specified in the job description.

What are the key responsibilities for this Quality Assurance Manager role?

Responsibilities include acting as GQP Quality Assurance Manager for GMP management, shipping, factory audits, change/deviation/complaint/recall processing, self-inspection, training, SOP creation/revision, QMS record management, and supporting new product introductions and regulatory compliance.

What is the company culture like at Vantive?

Vantive fosters a community of focused, courageous people who don't settle for mediocrity and are driven to improve patients' lives worldwide through innovations in vital organ therapies.

What skills or experience make a strong candidate for this role?

Strong candidates will have specialized knowledge of GQP and QMS regulations, experience as a Quality manager under pharma/MD MAH, and expertise in GMP management, factory audits, deviation processing, SOP creation, and supporting regulatory compliance for new products.

Vontive

Provides investment property mortgage solutions

About Vontive

Vontive provides investment property mortgages using technology to simplify and speed up the loan process. Their main product is a "bolt-on" technology that allows retail brands to easily launch their own mortgage services without needing programming skills. This no-code solution can be set up in just a few weeks, making it quicker for brands to offer mortgages. Vontive stands out from competitors by acting as a bridge between real estate investors, lenders, and capital providers, charging fees for their services that reduce traditional risks and inefficiencies in real estate financing. The company's goal is to modernize the investment real estate market by making the mortgage process more efficient and transparent for both retail brands and financial institutions.

San Francisco, CaliforniaHeadquarters

2017Year Founded

$32.1MTotal Funding

DEBTCompany Stage

Financial Services, Real EstateIndustries

11-50Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Unlimited Paid Time Off

Parental Leave

Short- and Long-term Disability Coverage

Life Insurance

Wellness Program

Risks

Increased competition from fintech companies could erode Vontive's market share.

Potential regulatory scrutiny may lead to higher compliance costs and challenges.

Economic downturns could impact demand for investment property mortgages.

Differentiation

Vontive offers a no-code, white-label mortgage solution for real estate investors.

The platform integrates financial institutions through a unique debt marketplace.

Founded by industry veterans, Vontive leverages decades of mortgage and financial expertise.

Upsides

Vontive ranked #10 on the 2022 Deloitte Technology Fast 500 with 9,154% growth.

The company has financed over $1.1 billion in residential properties since April 2022.

Vontive's B2C ecosystem reaches over 1.5 million real estate investors.

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