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 Lead, IT Regulatory Compliance role provides operational support for the implementation, conduct and oversight of the IT Regulatory Compliance (IT RC) and Quality Computer System Validation (QCSV) internal & supplier 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 also leads and conducts 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 communicate compliance gaps, considering big picture risks, and gain business partner commitment to address issues. S/he will provide tactical GxP compliance expertise and leadership to business partners to ensure effectiveness of remediation action plans. This individual will report to the Manager, IT Regulatory Compliance.
Major Duties and Responsibilities:
Approximate Percentage of Time - Tasks/Duties/Responsibilities
- Leads and executes internal audits and periodic reviews covering key IT GxP related processes, large global portfolio of computerized systems covering 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.
- Leads and executes 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), Software as a Medical Device (SaMD), and Mobile Medical Apps (MMaps).
- Contribute to the content management for writing SOPs, WIs, Policies for the audit program
- Ensuring timely and effective resolution to CAPAs and audit observations related to the audit program
- Partner with audit observation owners to understand root cause analysis and develop appropriate remediation plans
- Provide on-going support for the Audit mailbox including the coordination and management of activities to provide requested support
- Maintain awareness of new and emerging technologies and regulatory requirements
- Support communications and distribution of final report for internal, external or 3rd party audits
- Supports Health Authority inspection readiness activities
- Assist with audit readiness activities for internal and external audits
- Performs gap assessments to new or evolving regulatory requirements and guidance.
- When applicable, leads the delivery of education and training on compliance requirements, procedures and controls.
- Builds and maintains trusting, collaborative relationships and partnerships with internal and external stakeholders to accomplish business objectives.
- Participates in industry and other professional networks to ensure awareness of industry standards, trends and best practices in order to strengthen GxP audit knowledge. Engages with industry groups (e.g., ISPE, AdvaMed) to understand and influence the external regulatory environment.
- Partners with stakeholders to assess, develop and implement solutions that enable compliant innovation.
- Supports JJRC enterprise initiatives by participating on working teams or acting as subject matter expert 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.
- A Bachelor’s degree is required. (Preferred Area of Study: Computer Science, Mathematics, Information Technology, Engineering or related discipline preferred)
- A minimum of 3 years of experience in IT (Information Technology), Compliance and/or QA (Quality Assurance) within a regulated industry.
- A minimum of 2 years of auditing experience in a regulated healthcare industry.
- Experience leading or participating in global virtual teams.
- Experience and knowledge of FDA computer system validation requirements, Quality System Regulations, ISO plus experience with external auditing bodies.
- Demonstrated experience in writing compliance documentation.
- 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.
- Up to 25% Domestic and international travel.
Preferred Knowledge, Skills and Abilities:
- Experience interacting with health authorities and/or notified bodies during inspections is preferred.
- Understanding of how regulatory bodies approach inspections and how to respond to Health Authority observations is preferred.
- CISA, ASQ, ISO Lead auditor or other auditor certification highly preferred.
- Knowledge of process design, development and continual improvement is desired
- Knowledge of process improvement experience such as Six Sigma, Lean and Design Excellence is a plus.
United States-New Jersey-RaritanOrganization
Johnson & Johnson Services Inc. (6090)Job Function
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.