Sr. Clinical Quality Auditor - Shockwave Medical

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Santa Clara, California, United States of America Job Description: Johnson & Johnson is hiring for a Sr. Clinical Quality Auditor– Shockwave Medical to join our team. This role is fully remote in the United States. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ . Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview The Sr. Clinical Quality Auditor will provide GCP and compliance-related audits of internal and external Clinical Studies in process, support updates of procedures in compliance with applicable regulations and perform vendor audits as needed. This work is accomplished with moderate oversight, requires frequent contact with internal and external customers and is critical to the success of the business. Essential Job Functions Act as a Clinical Quality Auditor Lead on clinical trials by supporting project team compliance with national and international regulatory standards and guidance for medical devices Support development of audit management plans and audit strategy for ongoing clinical trials Conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines and in alignment with internal audit plans Participate in the development of departmental standard operating procedures, work instructions, forms, and templates Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented/documented Support or conduct training for staff (GCP, Inspection Readiness training, etc.) Support regulatory inspections Review/revise Standard Operating Procedure (SOPs) and procedures as assigned Responsible for initial and ongoing audit of clinical study vendors such as CRO, imaging core lab, central laboratory and other vendors as needed Identifies and escalates site, vendor and study related issues to management, as appropriate This work is accomplished with moderate supervision and requires a motivated, self-starter who can work independently once projects are assigned Requirements · Bachelor’s Degree or equivalent experience in a scientific field of study · 5 years’ experience directly supporting clinical research, QA, or relevant experience in medical/scientific area. · Experience conducting audits of vendors and investigative sites · Experience interacting with regulatory authority inspectors · Experience preparing and supporting clinical study sites undergoing regulatory authority inspections · Experience revising SOPs and procedures · Thorough knowledge and application of Good Clinical Practice (GCP) is required, i.e. FDA, ISO 14155, MDR · Independent thinking and planning ability · Medical Device experience is preferred · Excellent written and verbal communication skills · Exceptional teamwork skills · Requires a motivated, self-starter who can work independently once projects are assigned. · Basic understanding of peripheral and coronary artery disease and therapies preferred · Knowledge and experience in supporting device pre- and/or post-market clinical studies is required · ACRP or SOCRA certification preferred · Ability to work in a fast-paced environment while managing multiple priorities across multiple projects · Operate as a team and/or independently while demonstrating flexibility to changing requirements · Must have excellent verbal and written communication skills · High attention to detail and accuracy Ability to travel up to 30%-40% of time domestically and internationally Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Cent