Senior Manager, Product Quality Management at Johnson & Johnson

Irvine, California, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

MedTech, Healthcare, Medical DevicesIndustries

Requirements

Experience in quality management, particularly in MedTech or healthcare innovation
Ability to partner with Supply Chain (Ops, Value stream), R&D, QA, and commercial leadership
Expertise in monitoring, analyzing, and improving brand quality from NPI through to the customer
Knowledge of regulatory and quality systems at operating company and enterprise levels
Leadership skills to manage two Engineering groups (NPI Quality Engineering and Customer Experience Engineering, over 20 engineers)
Accountability for strategic 10-year quality plans per brand, addressing patient needs
Signature authority on non-conformances, change control, quality plans, control plans, major changes, and validations for assigned product lines
Ability to communicate to all levels of the organization and integrate brand quality plans into the product value stream

Responsibilities

Lead the monitoring, analysis, and improvement of all aspects of brand quality from NPI through to the customer
Communicate brand health back to commercial to improve brand equity
Incorporate health authorities’ compliance landscape proactively into the improvement strategy
Lead the strategic 10-year overview quality plan per brand using new product and improvement approaches
Hold key quality decisions on the brands
Partner with commercial organization, regional offices, Regulatory, and Complaint handling to gather short- and long-term brand performance information
For new products, partner with R&D leadership to modify development, assess launches for product quality, and accelerate, modify, or delay launches
For existing products, partner with Supply Chain Leadership to assess and implement manufacturing process modifications and lead quality-related improvement strategies
Lead overarching CAPAs on product improvement topics in sync with R&D and Supply Chain engineering
Review and assess any brand-wide deviation from design intent, co-owning product decisions with site quality leader
Sign off on non-conformances and change control for assigned product lines
Accountable and signatory for quality plans, control plans, major changes, and validations
Communicate brand quality plans to all organizational levels, integrating into the product value stream with quantifiable business outcomes
Measured by brand scorecard health, including internal (NCs, Quality events) and external quality metrics

Skills

Quality Management

Quality Assurance

Product Quality

Supply Chain Management

R&D Collaboration

Regulatory Compliance

NPI

Strategic Planning

Data Analysis

Risk Management

Compliance Monitoring

Brand Health Analysis

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

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