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:

Cincinnati, Ohio, United States of America, Horsham, Pennsylvania, United States of America, Irvine, California, United States of America, Jacksonville, Florida, United States of America, Raritan, New Jersey, United States of America, Raynham, Massachusetts, United States of America, Tampa, Florida, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Lead, Technology Compliance! This position can be located at any J& J Innovative Medicine site, with a preference for Raritan, NJ.

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-012327

Beerse Belgium– #R-013806

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

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130, 000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

Position Summary:

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

This position is responsible for supporting audit and assessment corrective actions as part of closed loop audit and assessment programs, including Technology Supplier Audit and GxP System Periodic Review. This position is also responsible for providing direct support to business segments during Health Authority and other Third-Party audits related to Technology areas; and compliance metrics analysis and communication of risk themes to drive systemic actions when appropriate. This position assists in the continuous improvement of the compliance programs, including external regulatory outreach to shape emerging regulations in the areas of technology and innovative healthcare solutions.

This individual will report to the Head, Technology Compliance– Med Tech & Emerging Compliance.

Risk-Based Closed Loop Supplier Audit and Periodic Review Programs

• Leads and executes closed loop periodic reviews of J& J Segment (Innovative Medicine, Med Tech and Enterprise) GxP computerized systems that are supported by Enterprise Quality including a large global portfolio of computerized systems covering Manufacturing and Laboratory.
• Leads and executes closed loop technology supplier audits, covering GxP related software and technology 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, escalating any identified risk, and assisting with the continuous improvement of the follow up program.
• Assists in providing compliance SME inputs to TRC risk assessment process to ensure complex risk factors associated technology are incorporated into the framework.
• Partners with the Operations and Enterprise Quality groups to interpret and evaluate risk associated with internal audit and health authority inspection findings and provides compliance subject matter expertise to ensure the development of robust corrective action plans that address the root cause of issues.
• 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, guidances, and enforcement trends. Works with Quality partners to establish corrective actions to address any identified gaps.
• 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.
• Contributing to the content for writing SOPs, WIs and Policies for compliance programs.

External Advocacy and Communications

• Builds and maintains trusting, collaborative relationships and partnerships with internal and external stakeholders to accomplish business objectives.
• Maintain consistent touchpoints with process area stakeholders, business owners, and EQ leads.
• Maintain awareness of new and emerging technologies and regulatory requirements
• Ensure awareness of industry standards, trends and best practices in order to strengthen GxP knowledge.
• Participates in industry and other professional networks to ensure awareness of industry standards, trends and enforcement actions in order to strengthen compliance programs. Engages with industry groups (e.g., ISPE, AdvaMed) to shape the external regulatory environment.

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 technical subject matter experts to speak with investigators.
• Engages directly with health authority inspectors from regulatory agencies and assists/accompanies technical subject matter experts to engage with regulators as needed.
• Provides compliance input and final review of formal responses to health authority observations related to Enterprise Quality

Stakeholder Management, Compliance Expertise and Support for Innovation Initiatives

• Partners with stakeholders to assess, develop and implement solutions that enable compliant innovation. Identifies potential risks, articulates impact, and works with business partners to establish proactive risk mitigation strategies.

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

Other:

• This position may require up to 10% domestic & international travel
• This position has an estimated annual salary of $91, 000-$147, 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:

$91, 000-$147, 200

Additional Description for Pay Transparency:

• This position has an estimated annual salary of $91, 000-$147, 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