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.

About the role

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 role is fully remote in the United States and is critical to the success of the business.

Responsibilities

• 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
• Identify and escalate site, vendor, and study-related issues to management, as appropriate

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 a 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
• High attention to detail and accuracy
• Ability to travel up to 30%-40% of time domestically and internationally

Pay

The anticipated base pay range for this position is $91,000.00 - $147,200.00.

Benefits

• Retirement plan (pension) and savings plan (401(k))
• Long-term incentive program
• Vacation – 120 hours per calendar year
• Sick time – 40 hours per calendar year (48 hours for Colorado residents, 56 hours for Washington residents)
• Holiday pay, including Floating Holidays – 13 days per calendar year
• Work, Personal, and Family Time – up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member, 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year