Senior Project Manager - (Job Number: 0805912)

Senior Project Manager - (Job Number: 0805912) DescriptionEthicon, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Project Manager, located in Somerville, NJ. Ethicon, Inc. develops and markets products for surgery, wound management and advanced wound care treatment . Products are marketed through four divisions: Ethicon Products for precise wound closure and tissue repair; Cardiovations for minimally invasive cardiac procedures; Ethicon Women's Health & Urology for minimally invasive women's health procedures; and Johnson & Johnson Wound Management for hemostasis and advanced wound care.This individual will ensure internal audit program complies with QSR, ISO and international requirements. Assist in defining approach and governance for franchise wide quality system internal audit program including interface with site compliance leaders. Provide compliance and quality consultation as appropriate to other functions in the organization. Conduct franchise wide audits and gap assessments in support of the internal audit program and FDA Readiness. Monitor internal audit program performance through the use of trending and metrics. Serves as consultant, making recommendations and corrective actions, which are required regarding audit results, and compliance to written procedures or applicable government regulations. Maintain files containing audit reports, re'audit reports, and audit responses, and pertinent corrective action follow-up for audits conducted in support of the Franchise Internal Audit Schedule and Somerville Site Schedule. Escort outside auditors representing government agencies, vendors or those requested by management at all times during their audit. Reports findings of outside auditors to management. Review audit responses and assist with required training in response to audit findings and other GMP/ISO/JPAL related issues as needed. Provide advice and guidance to less seasoned Quality System Auditors. Assist in formulating regulatory policies and procedures to be followed by company personnel in compliance with local, state, and federal regulations through the development of Franchise Documents and Standard Operating Procedures regarding regulatory compliance. Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings. Alert organization to existing and potential compliance issues and risks. Collaborate with functional departments to establish effective CAPAs. Write, review and provide input to regulatory agency submissions. Oversee recalls and product quality issues to proper closure. Ensure effective internal audit program. Ensure effective FDA Readiness program. This individual will also be accountable for the absence of significant quality issues and regulatory compliance actions by government agencies. Identification and alerting of quality issues in time to resolve potential adverse effects to the customer, company image/reputation and/or the business. Accountable for effective regulatory agency inspections. A minimum of B.S. degree in a scientific or technical field is required. A minimum of 5 years experience in quality compliance is required. A quality auditor certification is required; certified lead auditor would be preferred. Experience with progressive quality systems, quality control, quality assurance experience, including hands on advanced quality systems compliance is required. Strong leadership ability, interpersonal, and communication skills are required. The ability to lead and influence other is required. Demonstrated compliance experience in domestic and international medical device and combination product quality systems is preferred. Strong technical, planning, and execution capabilities. Ability to analyze, balance, and prioritize risk. Direct experience with FDA inspections in a leadership role (not support) is required. This position is located in Somerville, NJ, and may require up to 25% travel. If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today! Apply Now