Johnson & Johnson, through its operating companies, 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. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.
The Director of Regulatory Compliance Assessments will conduct announced and unannounced audits across all Johnson & Johnson operating units to determine the ability of sectors and sites to meet regulatory compliance requirements. This individual will execute these audits, based on an approved audit schedule. The Director Regulatory Compliance Assessments will determine and document site inspection readiness, facility operating conditions, and adherence to Johnson & Johnson enterprise standard operating procedures and regulatory requirements by sector and local operating units. This individual will identify and communicate compliance status and common issues/trends via an independent audit assessment process, including appropriate rating of internal audits. This individual will also document all assessment findings and commitments accurately and timely in the Enterprise Quality and Compliance tracking systems and verify that those commitments have been taken and are effective. The Director Regulatory Compliance Assessments will report to the Sr. Director, Regulatory Compliance Enterprise Assessments.
A minimum of a Bachelors degree is required. An advanced degree is preferred. A focused degree in science, business, engineering, finance or organizational management is preferred. A minimum of 10 years of relevant industry experience is required. A minimum of 5 years of experience conducting and leading regulatory assessments in an international, global context, in a regulated healthcare environment is required. Functional knowledge of/and experience in Quality and Regulatory Compliance is required. Previous experience working inside a regulatory agency (i.e. FDA, MHRA) is preferred. Strong knowledge of quality and compliance in a regulated manufacturing environment is required. Knowledge of clinical trials and pre-clinical expectations (running protocols, conducting clinical trials, writing and filing reports with state, federal or international authorities) is preferred. Knowledge of regulatory and development process (both pre-approval and post launch monitoring) and scale up is preferred. Understanding of all requirements for compliant drug/device/biologic manufacture, including facilities, equipment, documentation, testing, and product flow is preferred. Knowledge of validation on computerized systems is required. Thorough understanding of how regulatory bodies approach inspections and how to respond to FDA observations is required. Remediation experience is preferred. Experience managing complex projects is required.
Excellent written and verbal communication, influencing, and negotiating skills are required to inspire trust and quickly build credibility within the Quality and Compliance community to enable the creative achievement of mutual goals. Strong interpersonal and technical skills are required to facilitate collaborations between Johnson and Johnson companies. This candidate will have proven experience driving progress and remaining focused under ambiguous and complex situations. The ability to take in the vital points of the audit and make big picture decisions and observations is required. In addition, this candidate will have strong consultant and leadership skills, while still being a team player and working well with others.
This position can be located at any Johnson & Johnson site and/ or home office. It will require up to 50% global travel, with higher peaks depending on business need.
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North America-United States-New Jersey-New Brunswick
North America, Europe/Middle East/Africa, Latin America, Asia Pacific
Johnson & Johnson Services Inc. (6090)
Johnson & Johnson - 10 months ago
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