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.

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

Required Skills:

Preferred Skills:
Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards

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

Additional Description for Pay Transparency:
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