HireDiversity

New Brunswick, NJ, US

Associate Director of Regulatory Compliance Assessments - McNeil Remediation Oversight-1536121130

Description

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 Associate Director of Regulatory Compliance Assessments - McNeil Remediation Oversight will conduct announced and unannounced audits of McNeil's manufacturing sites, contract facilities, and work plan verification assessments in preparation for the assessment of the overall compliance of McNeil's remediation. This individual will work with McNeil and Johnson & Johnson management and will report in to the Director of Johnson & Johnson, McNeil Remediation.

This individual will execute these audits based on the workplan due dates, audit schedule, or focused audits, as required in order to support the McNeil Remediation Oversight function. The Associate Director of Regulatory Compliance Assessments - McNeil Remediation Oversight will determine and document workplan completion status, sustainability of the McNeil Quality Systems, facility operating conditions, adherence to Johnson & Johnson enterprise standard operating procedures and compliance with cGMPs and associated regulatory requirements. This individual will identify and communicate compliance status and issues/trends. This individual will also document all assessment findings and commitments accurately and timely in the Enterprise Quality and Compliance tracking systems, participate in identifying corrective actions, where appropriate, and verify that commitments have been taken and are effective. The Associate Director Regulatory Compliance Assessments will also perform duties as assigned by the Director Regulatory Compliance McNeil Remediation.

Qualifications


A minimum of a Bachelors degree is required. An advanced degree or ASQ Certified Quality Auditor (CQA) is preferred. A focused degree in degree/studies in science, engineering, or equivalent is strongly preferred. A minimum of 8 years of relevant industry experience is required. A minimum of 3 years of experience conducting and leading regulatory assessments in a regulated healthcare environment 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 (GMPs) is required. Knowledge of regulatory and development process (both pre-approval and post launch monitoring) and scale up is preferred. An understanding of requirements for compliant drug manufacture including facilities, equipment, documentation, testing, and product flow is required. Knowledge of validation on computerized systems is preferred. Thorough understanding of how regulatory bodies approach inspections and how to respond to FDA observations is required. Working knowledge of New Drug Regulations and GxP/Quality System Regulations is required. Working experience in a Consent Decree environment is preferred. The ability to speak and write in Spanish is a plus.

Excellent written and verbal communication, influencing, and negotiating skills are required to inspire trust and quickly build credibility within the Quality and Compliance community. Strong interpersonal and technical skills are required to facilitate collaborations between Johnson and Johnson Quality and Compliance and McNeil management. 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 in the NJ/PA corridor, Las Piedras, Puerto Rico or Fort Washington, PA and may require up to 50% travel, with higher peaks depending on issues.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-New Jersey-New Brunswick
Other Locations:North America-United States-Pennsylvania, North America-United States-New Jersey, North America-United States-Puerto Rico-Las Piedras
Organization: Johnson & Johnson International (6078)
Job Function: Compliance