Enterprise Regulatory Compliance Auditor

Johnson & Johnson Ethicon INC a member of the Johnson & Johnson Family of Companies is recruiting for an Enterprise Regulatory Compliance Auditor! This role can be located within any Johnson & Johnson location. Remote work may be considered on a case-by-case basis and if approved by the business. Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com. The Enterprise Regulatory Compliance Auditor is responsible for performing Internal Manufacturing (IM), Supplier and/or External Manufacturer (EM) audits (by means of on-site or other tools) to verify compliance to applicable government regulations, standards and to company policies and procedures. Provides compliance expertise to the organization as required.] Key Responsibilities: Assures that auditee site quality system audit function complies with QSR/GMP, ISO and other regulatory requirements. Performs and/or leads audits of sites for compliance to applicable government regulations, material specifications, to international standards and to company policies and procedures. Performs re-audits of deficient matters and corrective actions, as needed, and required. Documents audit results in written audit reports that are distributed and reviewed by appropriate management. Timely and accurately issues and maintain files associated with audits, re-audits and corrective action responses, and performs updates in the applicable audit tracking systems. Maintains abreast of regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings. Supports JJRC base business projects and initiatives, as required. Qualifications Education: A minimum of a Bachelor’s or equivalent University degree is required. Masters or advanced degree preferred. Experience and Skills: Required: Minimum of eight years relevant work experience with a minimum of 5 years of experience conducting and leading regulatory assessments in a regulated healthcare environment Proven ability to conduct and manage audits. Knowledge dealing with the Worldwide Health Authorities inspections. Knowledge and skills in quality-related methods and techniques including auditing principles and techniques, quality terminology, quality management principles and their applications and quality management tools and their applications. Good written and oral English communication skills. Ability to read, analyze and interpret scientific and technical journals, financial reports, and legal documents. Strong understanding in FDA CFR Part 820, Part 11, ISO 130485 and/or other applicable regulations. Strong knowledge of quality and compliance in a regulated GxP/QMS environment. Ability to take in the vital points of the audit and make big picture decisions and observations. Ability to respond to common inquiries, regulatory agencies, or members of the business community. Statistical skills and manufacturing process understanding. Ability to stand firm while being open to new approaches. Engages in constructive conflict. High tolerance for ambiguity in a complex environment. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to build partnerships both internally and externally. Ability to effectively interface with governmental and independent auditors. Ability to use PC's and associated Microsoft software. Preferred: ASQ Certified Quality Auditor (CAQ) Computer Systems Validation experience Detailed knowledge of drug, cosmetic, OTC or medical devices regulatory requirements and auditing techniques Six Sigma, Lean, ISO lead auditor, or ASQ CQA certification and trainings Other: This role may require up to 50% of domestic & international travel At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families, and the communities in which we live and work. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.] Primary Location United States-Ohio-Cincinnati-4545 Creek Road Other Locations North America Organization Ethicon Inc. (6045) Job Function Quality Requisition ID 2206047215W