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
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.
- This role provides Regulatory Compliance support to the Johnson
& Johnson (J&J) family of companies as well as J&J IT partners.
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.
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
inspection readiness activities for internal and external audits/inspections
- Maintain awareness of new and emerging technologies and regulatory
- Partners with
stakeholders to assess, develop and implement solutions that enable compliant
- 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
- Ensures timely
completion of assigned training.
- 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
participating in global virtual teams
experience in drafting compliance related artifacts
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.
United States-New Jersey-RaritanOrganization
Johnson & Johnson Services Inc. (6090)Job Function