Job Function:
Legal & Compliance
Job Sub Function:
Enterprise Compliance
Job Category:
Professional
All Job Posting Locations:
Horsham, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America
Job Description:
Johnson & Johnson is currently recruiting for the best talent for a Lead, Technology Compliance to be located in Raritan, NJ, Horsham, PA, New Brunswick, NJ 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-089703
EMEA 6 Requisition# R-090248
The Lead, ERP & WMS Technology Compliance is responsible for execution and operational support of J&J Technology Quality & Compliance (JJTQ&C) global compliance programs.
Key Responsibilities:
- execution of closed loop audit and assessment programs, including Technology Supplier Audit and GxP system Periodic Reviews.
- providing direct support to business segments during global health authority inspections and other third-party audits related to Technology areas.
- compliance metrics analysis and communication of risk themes to drive systemic actions when appropriate.
Additionally, 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 position reports to the Head, Med Tech & Emerging Compliance.
Tasks/Duties/Responsibilities:
Risk-Based Closed Loop Supplier Audit and Periodic Review Programs
- Executes closed loop Supplier Audit and GxP System Periodic Review Programs, including conducting independent audits/reviews, providing independent oversight of audit planning, audit and assessment corrective actions, documenting results, reporting on follow-up status, escalating critical issues/risk to senior leadership,
- Plan, organize and execute comprehensive audits of GxP software and/or software technology service providers such as suppliers of infrastructure as a service (IaaS), Platform as a service (PaaS), Software as a Service (SaaS), encompassing the entire computerized system lifecycle to assess compliance with appropriate health authority regulations, guidance, company procedures and industry standards
- Partners with Technology Quality and Business Quality to execute gap assessments between current practices and new regulatory expectations, as communicated via health authority regulations, guidance, and enforcement trends. Works with Quality partners to establish corrective actions to address any identified gaps.
- Leads the resolution of complex situations that arise during execution of closed loop audit and assessment programs, including conflict resolution, articulates risks and impact, negotiates alignment and secures support for remediation actions that reduce risk.
External Advocacy and Communications
- 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. Engage with industry groups (e.g., ISPE, AdvaMed) to shape the external regulatory environment.
Inspection Readiness and Support
- Ensure 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
Compliance Expertise and Support for Base Business and Innovation Initiatives
- Provides compliance subject matter expertise and support to Technology Quality and sector Business Partners related to GxP processes in the end-to-end technology areas.
- 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, lead the development and delivery of education and training on compliance requirements, procedures and controls to key stakeholders
Perform other work-related duties as assigned.
- Ensures timely reports of status, metrics and time sheets as required by the Technology Quality & Compliance organization
- Ensures timely completion of assigned training and expense reports.
- Supports JJRC enterprise initiatives, including execution of JJRC independent audit program, projects, and special assignments.
- Proactively sense for opportunities and actively participate in compliance program development from the outset
Qualifications:
Education:
A minimum of a Bachelors or equivalent University degree is required.
Required Knowledge, Skills and Abilities:
- 3+ years of progressive experience in managing all aspects of Quality and Regulatory Compliance in an international, global context, in a regulated healthcare environment.
- Expert 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 and software medical devices.
- Auditor experience in a regulated industry, preferably HealthCare Industry
- Expert knowledge of IT internal controls, SDLC methodologies, GAMP5, data integrity requirements.
- Experience effectively interfacing with global regulatory agencies, e.g., FDA, MHRA, TGA, notified bodies, etc.
- Experience interpreting regulations and translating regulatory requirements into practical strategies.
- Ability to resolve complex regulatory compliance issues.
- Ability to analyze and interpret regulatory documents.
- Proven experience in driving progress to strategic plans and remaining focused under ambiguous and complex situations.
- Excellent written and oral communication skills, including proven ability to make technical and complex topics clear and easily understood orally and in writing.
- Ability to effectively present information to executive management.
- Ability to lead teams and build strong cross-functional relationships.
- Ability to influence, negotiate, and build credibility.
- Strong skills in interdependent partnering to facilitate collaboration.
- Audit management and delivery
- Analytical mindset
Preferred Knowledge, Skills and Abilities:
- Expertise in medical device quality, including standards for medical device software development and risk management preferred (e.g., ISO, IEC, AAMI)
- Experience in regulatory affairs areas, including knowledge of 510K and PMA submission process (or global equivalent).
- Experience in establishing Quality Management Systems.
- Auditor experience.
- Project Management
- Data analysis and reporting
- Risk-based audit framework development and execution
- Audit logistics coordination
Other:
This position may require up to 20% domestic & international travel.
Required Skills:
Preferred Skills:
The anticipated base pay range for this position is :
$94,000.00 - $151,800.00
Additional Description for Pay Transparency:
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 Colorado 48 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 30 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave 80 hours in a 52-week rolling period10 days
Volunteer Leave 32 hours per calendar year
Military Spouse Time-Off 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
