Associate Director, Enterprise Quality Management Systems Job in New Brunswick, New Jersey Us
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 Enterprise Quality Systems is responsible for helping to define the QMS strategy and implementation plan for quality and compliance initiatives that drive growth, improve product quality, increase patient safety, and also identify, escalate, and mitigate risks for the JJ enterprise. The position collaborates globally with Enterprise, Sector, and Operating Company organizations. This role will assist in conducting a comprehensive Voice-Of-Customer (VOC) that collects current state information within the Quality Organization including processes, business priorities, and computer applications in order to drive Quality System simplification and standardization. The position will help develop and implement various QMS processes by sector that roll up to support the Enterprise and will establish detailed IT project plans to complete a phased implementation.
Qualifications
A minimum of a Bachelors degree is required. A focused degree in engineering, technology or a scientific discipline is preferred. An advanced degree is preferred. A minimum 8 years of business experience is required. A minimum of 5 years of experience in Quality Management Systems working in a regulated environment is required. Direct experience with multiple plants/sites, with specific quality and compliance competencies in the areas of: Management Review, Training, Document and Data Control, Auditing, CAPA, Computerized System Validation, and Statistical Techniques is preferred. Experience supporting multi-site, global projects or programs is required. Experience in multi-cultural / multi-country locations is a plus. Proven success in strategy development and the implementation of Quality Management Systems, such as FDA 21 CFR part 210 211(drug) or FDA 21 CFR part 820 (device) and FDA 21 CFR part 11(IT) is required. Experience implementing QMS of ISO 13485:2003 and internal/external auditing of Quality Management Systems in the drug, biologic, blood, or device industry is also required. Experience in Computerized System Verification, Validation, and Software Lifecycle Development and Implementation (IEC/ISO 62304) is preferred. Experience working with regulatory authorities such as the FDA, and/or MHRA and EMEA is also preferred.
Strong presentation and communication skills are required. Demonstrated ability to negotiate and influence others is required. The ability to work collaboratively across multiple functions, countries, and cultures is required.
Position located in New Brunswick, NJ with 20% international/domestic travel.
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