Associate Director, Centralized Compliance Services

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

Job Function : Legal & Compliance

Job Sub Function :

Enterprise Compliance

Job Category : Professional

All Job Posting Locations :

Horsham Pennsylvania United States of America Raritan New Jersey United States of America

Job Description :

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

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s) :

North America- Requisition #R-044264

Beerse Belgium-Requisition# R-045004

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

Position Summary :

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. This 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%)

• Owns the Regulatory Standards Management program for Enterprise Quality. Partners with Technology Services and Enterprise Quality to execute gap assessments between current practices and new / changing regulatory expectations and ensures integration of changes into business processes including monitoring of implementation status. Facilitate quarterly meetings with Standards Council including formal documentation of meeting minutes in QMS. Manage notification and formal escalation process regarding uncovered gaps and remediation steps.
• Partners with TRC Operations and contributes content for the development of schedules and resourcing.
• Negotiate alignment and secure support for audit and gap assessment remediation actions across Sector and functional groups.
• Provides compliance SME inputs to TRC risk assessment process to ensure complex risk factors associated with technology are incorporated into the framework.
• Owns and lead Technology Services Health Authority inspection readiness program including authoring procedures supporting data center and site readiness front room and back-room management and Subject Matter Expert (SME) preparation.
• Engage directly with health authority inspectors from regulatory agencies on matters related to IT processes computer system validation and other technical topics and assist / accompany technical subject matter experts to engage with regulators as needed.
• Owns Health Authority inspection support program for segments including intakes from process areas across Innovative Medicine MedTech and Technology Services (TS) and managing inspection request with key stakeholders from JJT-TS and EQ. Ensures continuous expansion of program to cover emerging areas such as medical device software development and digital health.
• Ensures timely and effective support is provided to J&J Operating Companies globally including working with inspection site leadership to understand Technology Services and Technology Quality related inspection requests strategizing an approach for regulatory interactions and preparing technical subject matter experts to speak with investigators.
• Provides expertise in interpreting and evaluating risk associated with inspection findings and provides direction and p compliance input and final review of formal responses to health authority observations related to Technology Services and / or Technology Quality.
• Leads the development and delivery of education and training on inspection process lessons learned and key takeaways to key stakeholders.
• Leads communication efforts for inspection engagement to key stakeholders.
• When applicable leads and / or supports the delivery of education and training on compliance requirements procedures and controls.

Compliance Program Management (20%)

External Advocacy (20%)

Stakeholder Management Compliance Expertise and Support for Innovation Initiatives (10%)

Qualifications : Education :

A minimum of a Bachelors or University degree is required with a focus science IT engineering business or QRC discipline is highly preferred

Required :

Preferred :

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 . internal employees contact AskGS to be directed to your accommodation resource.

Required Skills : Preferred Skills :

Computer System Validation (CSV) Inspection Management System Regulatory Compliance

The anticipated base pay range for this position is :

$120000-$207000 USD$

Additional Description for Pay Transparency :

Subject to the terms of their respective plans employees and / or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs : medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance. Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire Employees are eligible for the following time off benefits : Vacation 120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year Holiday pay including Floating Holidays 13 days per calendar year Work Personal and Family Time - up to 40 hours per calendar year Parental Leave 480 hours within one year of the birth / adoption / foster care of a child Condolence Leave 30 days for an immediate family member : 5 days for an extended family member Caregiver Leave 10 days Volunteer Leave 4 days Military Spouse Time-Off 80 hours Additional information can be found through the link below. Experience :

Director

Key Skills

CCNP,Children Activity,Corporate Paralegal,Graphic Designing,Advertising,Import & Export

Employment Type : Full-Time

Experience : years

Vacancy : 1