Site Quality Director at Johnson & Johnson

Añasco, Puerto Rico, Puerto Rico

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Healthcare, MedTech, Pharmaceuticals, Vision CareIndustries

Requirements

Passion for improving and expanding vision treatments
Expertise in quality operations, compliance, and regulatory requirements in a manufacturing environment (implied by role leadership in Johnson & Johnson Surgery Vision Quality Operations)
Leadership experience managing direct reports in inspection, release of materials, Quality Engineering, and Quality Systems
Ability to define short- and long-term strategies for the facility
Strong collaboration skills with cross-functional teams (e.g., Operations, Make Engineering, Production Planning, Logistics, Product Management, Franchise Quality)
Experience serving as Quality Systems Management Representative
Capability to host 3rd party audits and present in executive reviews (e.g., Quality and Compliance Executive Reviews, Management Reviews, Quality Boards)
Skills in evaluating quality events, risk management, and non-conforming materials
Ability to report on Quality Management System effectiveness and promote regulatory/Quality awareness
Coaching and development skills for teams

Responsibilities

Leads the Johnson & Johnson Surgery Vision Quality Operations organization, ensuring compliance with quality and regulatory requirements and continuous supply to customers
Defines short- and long-term strategies for the facility
Accountable for inspection and release of incoming raw materials, in-process, and final Quality inspection/testing through direct reports
Directs the Quality Engineering team and Quality Systems site execution
Engages and collaborates with Franchise Quality teams and cross-functional Supply Chain functions for resource management and prioritization
Serves as local Quality Systems Management Representative for the site
Operates tactically in operations to provide timely Quality decision making
Oversees management of day-to-day quality activities
Makes decisions on non-conforming material per Quality System procedures
Evaluates and communicates quality events for elevation to Risk Management Board and/or Quality Board
Develops site operational Quality strategy as business partner to Supply Chain Operations and Franchise QA to optimize performance, compliance, and systems
Serves as Host for 3rd party audits; participates and presents in Quality and Compliance Executive Reviews, Management Reviews, Quality Boards
Reports to Executive Management on Quality Management System effectiveness and improvement needs
Promotes awareness of regulatory and Quality Management Systems requirements organization-wide
Ensures documentation of processes needed for the Quality Management System
Evaluates site Quality Operations capabilities, identifies gaps, recommends resolutions to Executive Management
Develops and leads innovative initiatives to improve business performance and support visionary changes
Provides coaching

Skills

Quality Management

Regulatory Compliance

Quality Operations

Strategic Planning

Leadership

FDA Compliance

Supply Chain Management

Continuous Improvement

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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