Sr. Clinical Quality Auditor- Shockwave Medical (Remote)

Johnson & Johnson•Santa Clara, CA

16h•$91,000 - $147,200•Remote

About The Position

Johnson & Johnson is hiring for a Sr. Clinical Quality Auditor – Shockwave Medica l to join our team. The position is FULLY REMOTE and can sit anywhere in the US. 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.

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
Ability to travel up to 30%-40% of time domestically and internationally
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

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
This work is accomplished with moderate supervision and requires a motivated, self-starter who can work independently once projects are assigned
Other duties as assigned.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits