Senior Analyst Technology Compliance

Johnson & Johnson; Raritan (NJ); On-site; USD 77,000 - 125,000; Full time

Job summary

A leading healthcare company seeks a Senior Analyst in Technology Compliance to support compliance programs, audits, and inspections. The role involves collaboration with various stakeholders and continuous improvement of compliance metrics. Ideal candidates will have a strong background in compliance and audit processes.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Short- and Long-term Disability

401(k) Plan

Vacation Time

Sick Time

Holiday Pay

Qualifications

• Responsible for operational support for Enterprise Quality compliance programs.
• Assists in reporting compliance metrics and continuous improvement.

Responsibilities

• Executes closed loop audit and assessment programs.
• Builds relationships with internal and external stakeholders.
• Ensures timely support for inspections and audits.

Skills

Compliance

Audit

Data Analysis

Education

Bachelor's Degree

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com

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, Tampa, Florida, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Senior Analyst, Technology Compliance! This position can be located in Raritan, NJ, Horsham, PA or Tampa, FL.

_At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com/. _

Position Summary:

The Senior Analyst, Technology Compliance is responsible for providing operational support for the execution of Enterprise Quality compliance programs.

This position is responsible for execution of closed loop audit and assessment programs, including Internal Audit, Supplier Audit, and GxP System Periodic Reviews associated with JTT-TS QMS. This position is also responsible for providing direct support to business segments during Health Authority and other Third-Party audits related to Technology areas. This position assists in the reporting of compliance metrics and data, as well as continuous improvement of the compliance programs.

This individual will report to the Head, Technology Compliance.

Risk-Based Closed Loop Supplier Audit and Periodic Review Programs

• Executes closed loop periodic reviews of J&J Segment (Innovative Medicine, Med Tech) GxP computerized systems that are supported by Enterprise Quality including a large global portfolio of computerized systems.
• Executes closed loop supplier audits, covering GxP related software and service providers, including suppliers of infrastructure as a service (IaaS), Platform as a service (PaaS), Software as a Service (SaaS)
• Assists in providing independent oversight of audit and assessment corrective actions, documenting results, reporting on follow-up status and escalating any identified risk.
• Assists in providing compliance SME inputs to TRC risk assessment process to ensure complex risk factors associated technology are incorporated into the framework.
• Assists in the continuous improvement of Enterprise Quality compliance programs associated with remediation follow-up activities for new regulation gap closure; health authority observation commitments; internal audits; supplier audits; and computerized system periodic reviews.
• Contributes to the content for writing SOPs, WIs and Policies for compliance programs.

Compliance Metrics and Data

• Supplies data to support information required for metrics and management review decks per the required cadence and ad hoc, as requested.
• Supports development and reporting of key data related to inspections, audit and periodic review program artifacts, and audit status.
• Supports risk framework processes to drive data-based prioritization of key compliance programs, including GxP System Periodic Reviews and Technology Supplier surveillance evaluations.
• Conducts collection of reporting requirements, including enhancements and additional reporting/analytics needs.
• Works closely with multiple business partners to understand and interpret the organization’s desired outcomes, manage requirements, and enable creative dashboards, visualizations, and analysis reports for TRC use.

External Advocacy and Communications

• Builds and maintains trusting, collaborative relationships and partnerships with internal and external stakeholders to accomplish business objectives.
• Maintain awareness of new and emerging technologies, regulatory requirements and industry standards, trends and best practices to strengthen GxP knowledge.
• Assisting Enterprise Quality and Business Quality groups to execute gap assessments between current practices and new regulatory expectations, as communicated via new health authority regulations, guidance, and enforcement trends. Works with Quality partners to establish corrective actions to address any identified gaps.

Inspection Readiness and Support

• Ensures timely and effective support is provided to J&J Operating Companies globally, including working with inspection site leadership to understand Enterprise Quality related inspection requests and preparing subject matter experts to speak with investigators.
• Assists in engaging directly with health authority inspectors from regulatory agencies and assists/accompanies subject matter experts to engage with regulators as needed.
• Participates in industry and other professional networks to ensure awareness of industry standards, trends and enforcement actions to strengthen compliance programs. Engages with industry groups (e.g., ISPE, AdvaMed) to shape the external regulatory environment.

Stakeholder Management, Compliance Expertise and Support for Innovation Initiatives

• Provides compliance support to innovation initiatives and key projects.
• When applicable, leads and/or supports the delivery of education and training on compliance requirements, procedures and controls.

Other:

• This position may require up to 10% domestic & international travel.
• This position has an estimated annual salary of $77,000- $124,200 USD$
• Employees and/or eligible dependents may be 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.
  - Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
  - Employees are eligible for the following time off benefits:
  - Vacation – up to 120 hours per calendar year
  - Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
  - Holiday pay, including Floating Holidays – up to 13 days per calendar year
  - Work, Personal and Family Time - up to 40 hours per calendar year

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com

The anticipated base pay range for this position is :

$77,000- $124,200 USD

Additional Description for Pay Transparency:

•This position has an estimated annual salary of $77,000- $124,200 USD$ • Employees and/or eligible dependents may be 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. - Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). - Employees are eligible for the following time off benefits: - Vacation – up to 120 hours per calendar year - Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year - Holiday pay, including Floating Holidays – up to 13 days per calendar year - Work, Personal and Family Time - up to 40 hours per calendar year