Lead, Technology Compliance

Johnson & Johnson; Raritan (IL); On-site; USD 91,000 - 148,000; Full time

Job summary

Join a forward-thinking company as a Lead in Technology Compliance, where your expertise will drive compliance initiatives across innovative healthcare solutions. This role involves leading audits, supporting regulatory compliance, and fostering collaboration with stakeholders to enhance quality systems. You'll play a pivotal role in shaping compliance strategies while ensuring readiness for inspections. With a focus on continuous improvement, you'll contribute to a culture of excellence and innovation, making a significant impact on health outcomes globally. If you're passionate about quality and compliance in healthcare, this opportunity is perfect for you.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Short- and Long-term Disability

401(k) Retirement Plan

Vacation Time

Sick Leave

Holiday Pay

Work-Life Balance Programs

Qualifications

• 3+ years in Quality and Regulatory Compliance in healthcare.
• Experience with information systems auditing in Pharma/Medical Device.
• Knowledge of Quality System regulations and data integrity.

Responsibilities

• Lead Technology Quality compliance programs and audits.
• Provide operational support for audit corrective actions.
• Engage with health authority inspectors for compliance.

Skills

Quality and Regulatory Compliance

Information Systems Auditing

GxP Regulations

SDLC Methodologies

Data Integrity Requirements

Analytical Skills

Communication Skills

Education

Bachelor's Degree in a related field

Relevant certifications (e.g., ISO, ICH)

Tools

Quality Management Systems

Audit Management Software

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 Lead, 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 Lead, Technology Compliance is responsible for providing operational support for the execution of Technology 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.

Risk-Based Closed Loop Supplier Audit and Periodic Review Programs

• Leads and executes closed loop periodic reviews of J&J Segment (Pharm, Med Tech and Enterprise) GxP computerized systems that are supported by Technology 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 Technology 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 Technology 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 Technology 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 TQ&C 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 Technology 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 Technology 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 Duties

• Supports JJRC enterprise initiatives by participating on working teams or on special assignments.
• Assists with the timely reporting of status and metrics as required by the IT Regulatory Compliance organization.
• Ensures timely completion of assigned training.
• Actively engage and/or lead projects within the TQ&C organization.
• Proactively sense for opportunities and actively participate in compliance program development from the outset

Required Knowledge, Skills and Abilities:

• 3+ years of experience in managing all aspects of Quality and Regulatory Compliance in an international, global context, in a regulated healthcare environment
• Experience in information systems auditing within Pharmaceutical/Medical Device company or minimum of 2 years of direct experience with development, implementation and/or validation of computerized systems within Pharmaceutical/Medical Device company.
• Experienced knowledge of Quality System regulations, ISO, ICH, PIC/S, and cGMP regulations, including Annex 11, 21 CFR Part 11, Part 210, Part 211 and Part 820, and how these apply to Computer Systems.
• Experienced knowledge of IT internal controls, SDLC methodologies, GAMP5, data integrity requirements.
• Experience interpreting regulations and translating regulatory requirements into practical strategies.
• Demonstrated experience in writing compliance documentation
• Ability to analyze and interpret regulatory documents.
• Demonstrated ability to support complex projects, priorities and multiple tasks
• Excellent verbal and written communication skills
• Ability to influence, negotiate, inspire trust, and quickly build credibility to enable the achievement of mutual goals.
• Strong skills in interdependent partnering to facilitate collaboration.
• Ability to perform work with a high degree of independence and proven experience in driving progress and remaining focused under ambiguous and complex situations.
• Ability to work effectively in a virtual team environment.
• Stakeholder and team coordination
• Analytical mindset

Preferred Knowledge, Skills and Abilities:

• Expertise in data platform architecture or cybersecurity frameworks, including standards for secure system development, data governance, and risk management, preferred. Knowledge of emerging technologies, such as advanced analytics platforms, AI-driven cybersecurity tools, or cloud-native data solutions, is a plus.
• Experience working with Quality Management Systems.
• Auditor experience. 2+ years of experience with auditing, Risk Assessment and Management and Nonconformance/CAPA system in a regulated industry, preferably Health Care Industry
• Knowledge of process design, development and continual improvement is desired
• Experience effectively interfacing with global regulatory agencies, e.g., FDA, MHRA, TGA, notified bodies, etc.
• Audit management and delivery
• In-depth and up-to-date compliance knowledge
• Audit logistics coordination
• Data analysis and reporting
• Risk-based audit framework development and execution

Other:

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

•This position has an estimated annual salary of 91,000 to 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 to 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