IT Lead, Regulatory Compliance
Location:
Raritan , New Jersey
Posted:
March 25, 2017
Reference:
6476170306-en-us

Johnson & Johnson Family of Companies. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

 

With $70.1 billion in 2015 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services for the consumer, pharmaceutical, and medical devices and diagnostics markets. The more than 265+ Johnson & Johnson operating companies employ approximately 126,500 people in 60 countries throughout the world.

 

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion.  Proud to be an equal opportunity employer.

 

This role provides operational support for the implementation, conduct and oversight of the IT Regulatory Compliance (IT RC) and Quality Computer System Validation (QCSV) internal audit program and the Periodic Reviews of computer systems.  This includes the Risk Based approach to conduct audits of IT related GxP processes and periodic review of GxP computerized systems across the Johnson & Johnson family of companies to ensure compliance with global GxP regulations and J&J internal Standards.

 

This individual will also support conduct, execution and reporting for audits of suppliers of GxP related software and technology services to assess the quality of products and services and to support a risk based approach to computer system validation and lifecycle management. This individual will report to the Manager, IT Regulatory Compliance.

 
Responsibilities
  • This role provides Regulatory Compliance support to the Johnson & Johnson (J&J) family of companies as well as J&J IT partners.
  • Provides operational support for the execution, conduct and reporting of internal audits and periodic reviews covering key IT internal GxP systems. The scope of internal IT systems will include Supply Chain, Manufacturing, Laboratory, Commercial and R&D, including ERP systems (e.g., SAP, JDE), Manufacturing Execution Systems (MES), Warehouse Management System (WMS), Laboratory Information Management Systems (e.g., LIMS and Empower), Quality Systems (e.g., CAPA, Non-Conformance, Change Control, etc.) Enterprise Master Data Management (EMDM) and Data Warehousing.
  • Provides operational support for the execution, conduct and reporting of supplier audits. The scope will include 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), Software as a Medical Device (SaMD), and Mobile Medical Apps (MMaps).
  • Provide on-going support for the global IT related regulatory inspections
  • Supports inspection readiness activities for internal and external audits/inspections
  • Maintain awareness of new and emerging technologies and regulatory requirements
  • Partners with stakeholders to assess, develop and implement solutions that enable compliant innovation. 
  • Partner with Enterprise Regulatory Outreach (ERO) on IT related topics to support outreach and awareness activities.
  • Supports JJRC enterprise initiatives by participating on working teams or acting as subject matter expert on special assignments as needed.
  • Assists with the timely reporting of status and metrics as required by the IT Regulatory Compliance organization.
  • Ensures timely completion of assigned training.


Qualifications
  • 2+ years of experience in IT, GxP Compliance and/or QA in a regulated industry
  • 1+ years of auditing experience in a regulated healthcare industry
  • 2+ years of experience with FDA and global regulatory requirements (e.g. Annex 11, 21 CFR Part11, Part 820 etc.)  for Computer System Validation, Electronic Records and Signatures, and Quality System Regulations
  • Experience participating in global virtual teams
  • Demonstrated experience in drafting compliance related artifacts  
  • Demonstrated ability to support complex projects, priorities and multiple tasks as assigned
  • Knowledge of process design, development and continual improvement is desired
  • 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.


Primary Location
United States-New Jersey-Raritan
Organization
Johnson & Johnson Services Inc. (6090)
Job Function
IT Compliance

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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