Sr. Clinical Quality Auditor - Shockwave Medical
About The Position
Johnson & Johnson is hiring for a Sr. Clinical Quality Auditor– Shockwave Medical to join their team. This role is fully remote in the United States. At Johnson & Johnson, the company believes health is everything and their strength in healthcare innovation empowers them to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through their expertise in Innovative Medicine and MedTech, they 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. Fueled by innovation at the intersection of biology and technology, they’re developing the next generation of smarter, less invasive, more personalized treatments. The team is pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Their 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.
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
Nice To Haves
- Medical Device experience is preferred
- Basic understanding of peripheral and coronary artery disease and therapies preferred
- ACRP or SOCRA certification preferred
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
- Identifies and escalates site, vendor and study related issues to management, as appropriate
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- 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 period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
