Associate Director, Centralized Compliance Services

Associate Director, Centralized Compliance Services

Johnson & Johnson is currently recruiting for Associate Director, Centralized Compliance Services. This position can be located in Raritan, NJ, Horsham, PA or Beerse, Belgium.

The Associate Director, Centralized Compliance Services has end-to-end leadership responsibility for centralized services, capabilities, and strategies supporting Technology Regulatory Compliance (TRC) functional effectiveness, including ownership, management and execution of Johnson & Johnson Technology Services (JJT-TS) and Enterprise Quality (EQ) core compliance programs for Regulatory Standards Management, Inspection Support and JJT-TS Inspection Readiness.

The position will be responsible for providing inputs to TRC risk assessment processes and informing future state audit processes based on data-driven analysis. The position will partner with JJT-TS, EQ and business Segments to ensure that J&J Quality Standards and global regulatory requirements are met and will drive integration of new or changing regulations into the JJT-TS QMS and operational processes, including monitoring implementation status. This position maintains awareness of the external regulatory landscape and is responsible for external regulatory outreach to shape emerging regulations in the areas of technology and innovative healthcare solutions. This position drives compliance metrics analysis and communication of risk themes to drive systemic actions when appropriate. This position owns the Inspection Readiness program for JJT-TS, including Data Center Inspection Readiness and direct support to business segments during Health Authority and other Third-party audits related to technology areas. The position is also responsible for compliance metrics analysis and communication of risk themes related to inspections to drive systemic actions when appropriate.

Responsibilities include portfolio and program management for TRC Compliance Programs; lifecycle management of TRC functional systems and deployment of new digital solutions. This will also include establishing strategies and methods to support a knowledge sharing culture that enhances talent capabilities, including future readiness, retention, pipeline growth.

This role provides GxP compliance support to base business and innovation initiatives, including, but not limited to, emerging healthcare technology such as RPA, Digital Products, AI / ML, etc.

This position reports solid line to the Head, JJRC Technology Regulatory Compliance within the Johnson and Johnson Regulatory Compliance (JJRC) organization.

Key Responsibilities :

• Compliance Programs Ownership Standards Management, Inspection Support and JJT-TS Inspection Readiness (50%)
• Compliance Program Management (20%)
• External Advocacy (20%)
• Stakeholder Management, Compliance Expertise and Support for Innovation Initiatives (10%)

Qualifications :

Other :

This position may require up to 20% domestic & international travel

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via contact us . internal employees contact AskGS to be directed to your accommodation resource.

Required Skills : Computer System Validation (CSV), Inspection Management System, Regulatory Compliance