Associate Director, Centralized Compliance Services at Johnson & Johnson

Beerse, Flanders, Belgium

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, MedTechIndustries

Requirements

Leadership experience in end-to-end management of centralized compliance services and strategies
Expertise in Technology Regulatory Compliance (TRC), Johnson & Johnson Technology Services (JJT-TS), and Enterprise Quality (EQ) core compliance programs
Knowledge of GxP compliance, Quality Management Systems (QMS), and global regulatory requirements
Ability to provide inputs to TRC risk assessment processes and inform future state audit processes using data-driven analysis
Experience partnering with JJT-TS, EQ, and business segments to integrate new or changing regulations into operational processes
Awareness of external regulatory landscape and capability for external regulatory outreach in technology and innovative healthcare solutions
Proficiency in compliance metrics analysis and communication of risk themes to drive systemic actions
Ownership experience in Inspection Readiness programs, including Data Center Inspection Readiness and support for Health Authority/Third-party audits
Skills in portfolio and program management for compliance programs, lifecycle management of functional systems, and deployment of digital solutions
Ability to establish strategies for knowledge sharing, talent development, retention, and pipeline growth
Experience providing GxP compliance support to base business and innovation initiatives (e.g., RPA, Digital Products, AI/ML)

Responsibilities

Own and manage Regulatory Standards Management program for Enterprise Quality core compliance
Lead Inspection Support and JJT-TS Inspection Readiness programs (50% of role)
Provide inputs to TRC risk assessment processes and data-driven analysis for future state audits
Partner with JJT-TS, EQ, and business segments to ensure J&J Quality Standards and global regulatory requirements are met
Drive integration of new/changing regulations into JJT-TS QMS and operational processes, including monitoring implementation
Maintain awareness of external regulatory landscape and conduct outreach to shape emerging regulations in technology/healthcare
Perform compliance metrics analysis and communicate risk themes to drive systemic actions
Own JJT-TS Inspection Readiness program, including Data Center readiness and direct support to business segments during audits
Manage portfolio and program for TRC Compliance Programs
Oversee lifecycle management of TRC functional systems and deployment of new digital solutions
Establish strategies/methods to support knowledge sharing culture, talent capabilities, future readiness, retention, and pipeline growth
Provide GxP compliance support to base business and innovation initiatives (e.g., RPA, Digital Products, AI/ML)

Skills

Compliance

Regulatory Standards Management

Inspection Support

Inspection Readiness

Risk Assessment

Technology Regulatory Compliance

Enterprise Quality

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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