Manager, R&D Escalation Lead at Johnson & Johnson

Raritan, New Jersey, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, MedTechIndustries

Requirements

Expertise in US and international GCP/GLP/PV regulatory requirements, policies, SOPs, and unit/project-specific procedures applicable to IM R&D QMS processes and systems
Ability to maintain alignment and compliance with J&J Quality Standards, Standard Operating Procedures, Health Authority/Country Regulations, and guidelines

Responsibilities

Drive the execution of an efficient and effective R&D Quality Issue Escalation governance program to accurately track and proactively manage the escalation process
Prepare and present relevant Escalation data at various governance forums, including support for Global R&D QSMR (Quality System Management Review)
Lead independent monitoring on the state of the Escalation control, system health, and provide meaningful interpretation of trends and signals identified
Support audit and inspection readiness, including ad hoc data requests for quality issue escalations in scope of IM R&D and OCMO
Develop and facilitate mechanisms/processes to identify potential gaps or opportunities for improvement and recommendations to improve the escalation process and management of potentially significant quality events across IM R&D
Partner with organizations, functions, standards, and business process owners to drive strategies for quality and optimal process performance of GxP activities
Review effectiveness of dashboards and dashboard metrics to improve meaningful utility to owners, governance bodies, and senior leadership
Serve as Business Process Owner for R&D Quality Escalation process
Manage community of practice for R&D ELs (Escalation Leads) and QH (Quality Heads)
Drive continuous oversight and improvement of the Escalation process and system performance
Support key users in the process with onboarding, training, and process execution enablement
Use measurement, analysis, and evaluation for continual improvement of the Escalations Process and promote achievement of quality objectives through key process indicators
Identify processes and process outputs that must be monitored, including parameters and outputs for drawing conclusions on process performance and related roles & responsibilities

Skills

Key technologies and capabilities for this role

Quality SystemsR&D EscalationProcess ImprovementQMSTrainingKPIsMeasurementAnalysisEvaluation

Questions & Answers

Common questions about this position

What is the location for this position?

The role is located in Raritan, NJ or Horsham, PA.

Is this a remote position?

This information is not specified in the job description.

What is the salary range for this role?

This information is not specified in the job description.

What are the main responsibilities of this role?

The role involves driving the execution of the R&D Quality Issue Escalation governance program, preparing and presenting escalation data at governance forums, leading independent monitoring of escalation controls, supporting audit and inspection readiness, and developing mechanisms to identify process improvements.

What kind of experience makes a strong candidate for this position?

Strong candidates will have expertise in quality systems, experience managing escalation processes in R&D, skills in data analysis and trend interpretation, and the ability to drive process improvements and support audits.

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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