Lead, Quality Assurance at Baxter International

Minato-ku, Tokyo, Japan

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Medical DevicesIndustries

Requirements

Minimum 5 years of pharmaceutical quality experience and CMO management
Knowledge of GQP, GMP, QMS
Knowledge of PMD Act, GQP/GMP/QMS ordinances, and related regulations
Experience managing CMOs
Experience handling authority and overseas audits
GMP/QMS compliance experience
Experience managing inspections from application to completion
Knowledge of pharmaceuticals and medical devices
Analytical and negotiation skills
English proficiency
Willingness to take on new challenges
Positive mindset and teamwork
Preferred Requirements
University degree in medical/pharmaceutical fields and pharmacist license
Experience in medical device quality
Experience managing 2+ people
Experience in generic drug QA

Responsibilities

Manage, operate, and maintain GQP for pharmaceuticals
Provide GMP oversight for domestic and overseas manufacturers
Manage contract manufacturing organizations (CMOs)
Manage, operate, and maintain QMS for medical devices
Handle application, coordination, and execution of GMP/QMS compliance inspections
Perform quality assurance for assigned products
Manage change control
Manage non-conforming products
Communicate with manufacturing sites
Maintain Drug and Medical Device Files (quality standard documents and product standard documents)
Handle recalls and holds, including records management
Support new product introductions
Plan, arrange, monitor, and report self-inspections and internal audits
Handle authority and corporate audits, including management, response, and reporting
Other related tasks

Skills

GQP

GMP

QMS

Internal Audits

External Audits

Self-Inspections

Change Control

Non-Conforming Product Management

Compliance Inspections

Quality Assurance

Baxter International

Provides essential medical products and services

About Baxter International

Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.

Deerfield, IllinoisHeadquarters

1931Year Founded

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Parental Leave

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Commuter Benefits

Mental Health Support

Risks

Needle-free injection technology could disrupt Baxter's traditional injection-based therapies.

Shift to home healthcare may require Baxter to adapt its product offerings.

Growing digital health importance necessitates further investment from Baxter to stay competitive.

Differentiation

Baxter's acquisition of Hillrom enhances its comprehensive healthcare solutions portfolio.

Strong focus on patient-centric innovation sets Baxter apart in the healthcare industry.

Baxter's partnerships, like with Ayogo, leverage digital health for improved patient outcomes.

Upsides

Baxter's investment in Medically Home aligns with the growing home healthcare market.

Rising demand for personalized medicine offers Baxter opportunities for targeted therapies.

Expansion in telehealth supports Baxter's integrated healthcare solutions strategy.

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