Manager GxP Systems Oversight at Johnson & Johnson

Raritan, New Jersey, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, BiotechnologyIndustries

Requirements

Minimum of a Bachelor’s degree required, focus in Engineering, Life Sciences, or a related field preferred
Minimum 7 years of relevant experience required, experience in biologics, cell therapy, or related biopharmaceutical operations in Engineering, validation and maintenance is preferred
Demonstrated experience of cGxP regulations, FDA, EMA and other regulatory agencies
Proven track record managing compliance activities, audits, CAPAs, and SOP revisions
Experience performing risk assessments, gap analyses, and implementing corrective actions
Familiarity with QMS (Quality Management Systems) and validation processes
Excellent communication and interpersonal skills

Responsibilities

Lead investigations related to Engineering, Maintenance, and Utilities systems, automation, including data collection, root cause analysis, and coordinating cross-functional meetings
Drive continuous improvement initiatives to enhance team performance and GxP metrics
Track and ensure the timely completion of CAPAs resulting from investigations, audits, and compliance assessments
Oversee the revision process of SOPs alignment with global standards for Engineering, Maintenance, automation and Utilities to ensure regulatory compliance and operational accuracy
Conduct gap analyses to identify areas for improvement in systems related to QMS compliance
Develop and deliver training programs on GxP SOPs and compliance requirements, providing technical support to the teams
Serve as the primary contact during regulatory and internal audits and inspections, ensuring site readiness and compliance
Propose and implement innovative solutions to strengthen compliance posture, operational efficiency, and continuous improvement
Integrate Johnson & Johnson’s Credo and Leadership Imperatives into team goals and decision-making processes

Skills

GxP

SOP revisions

CAPA

Change Control

Quality Engineering

Compliance

Engineering Oversight

Maintenance

Facilities Management

Automation

Cross-functional Leadership

Regulatory Requirements

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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