Director, Compliance - (Job Number: 0804056)

Director, Compliance - (Job Number: 0804056) DescriptionAdvanced Sterilization Products, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director of Compliance, Irvine, CA. Advanced Sterilization Products (ASP) Division of Ethicon, Inc. is a leading innovator of technologies in the areas of sterilization, high level disinfection, cleaning of medical devices, and hand hygiene. ASP markets STERRAD Systems, the CIDEX Family of Products, and PREVACARE Antimicrobial Hand Gel. The company is focused on hospitals and surgery centers. The Director of Compliance would be responsible for establishing and maintaining quality assurance standards, which adhere to Good Manufacturing Practices, Quality System and ISO regulations. The candidate would provide regulatory compliance guidance and decision making for the company in order to be fully compliant with government and corporate requirements. The candidate would also be responsible for providing leadership to support cultural changes and process improvements and ensuring production schedules are met through adequate resources. The Director Compliance would be responsible for hiring, retaining and developing qualified personnel, as well as resolving all personnel issues and performing employee performance management. The candidate would be responsible for management and continuous improvement of the Quality Systems including:- internal/external audits, CAPA training and complaint handling. The candidate would provide guidance and direction for ASP Call Management, Complaint Handling, Implementation of Corrective and Preventive Action (CAPA) in response to complaint-based failure investigation. The Director of Compliance would manage Recall/Field correction activities, review product designs and establish procedures and techniques for the control of quality standards. The candidate would manage audit readiness processes and programs as well as manage FDA, ISO and corporate inspections. The candidate would plan, develop and direct implementation of techniques to ensure the maintenance of performance and quality levels in company's products and production processes, confer with customers to define and resolve product quality problems and coordinate and cooperate with senior management in the development and improvement of Quality Systems, policies, procedures and goals. The candidate will also participate in the development of functional strategic plans to support organizational goals. BS in life sciences, engineering, or Regulatory Compliance field is required. A Masters Degree in relevant field is preferred. Eight or more years of leadership experience in Quality Assurance and Quality Systems within the Medical Device, Diagnostic, or Pharmaceutical industry. The candidate must have demonstrated people development and leadership skills and result and a demonstrated practical application of Process Excellence/Six Sigma skills (black belt certification preferred). Experience with complaint handling and implementation of Corrective and Preventive Action (CAPA) in response to complaint-based failure investigation is required. Up to 20% travel domestic and international is required. 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