Johnson Johnson is recruiting for Sr. Clinical Quality Auditor for Shockwave Medical Inc located in Santa Clara, CA.
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/.
For more than 130 years, diversity, equity inclusion (DEI) has been a part of our cultural fabric at Johnson Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson Johnson, we all belong.
Position Overview
The Sr. Clinical Quality Assurance 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 FunctionsAct as a Clinical Quality Auditor Lead on clinical trials by supporting project team compliance with national and international regulatory standards and guidance for medical devicesSupport development of audit management plans and audit strategy for ongoing clinical trialsConduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines and in alignment with internal audit plansParticipate in the development of departmental standard operating procedures, work instructions, forms, and templatesReport audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented/documentedSupport or conduct training for staff (GCP, Inspection Readiness training, etc.)Support regulatory inspectionsReview/revise Standard Operating Procedure (SOPs) and procedures as assignedResponsible for initial and ongoing audit of clinical study vendors such as CRO, imaging core lab, central laboratory and other vendors as neededIdentifies and escalates site, vendor and study related issues to management, as appropriateThis work is accomplished with moderate supervision and requires a motivated, self-starter who can work independently once projects are assignedOther duties as assigned.Johnson Johnson is recruiting for Sr. Clinical Quality Auditor for Shockwave Medical Inc located in Santa Clara, CA.
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/.
For more than 130 years, diversity, equity inclusion (DEI) has been a part of our cultural fabric at Johnson Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson Johnson, we all belong.
Position Overview
The Sr. Clinical Quality Assurance 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 FunctionsAct as a Clinical Quality Auditor Lead on clinical trials by supporting project team compliance with national and international regulatory standards and guidance for medical devicesSupport development of audit management plans and audit strategy for ongoing clinical trialsConduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines and in alignment with internal audit plansParticipate in the development of departmental standard operating procedures, work instructions, forms, and templatesReport audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented/documentedSupport or conduct training for staff (GCP, Inspection Readiness training, etc.)Support regulatory inspectionsReview/revise Standard Operating Procedure (SOPs) and procedures as assignedResponsible for initial and ongoing audit of clinical study vendors such as CRO, imaging core lab, central laboratory and other vendors as neededIdentifies and escalates site, vendor and study related issues to management, as appropriateThis work is accomplished with moderate supervision and requires a motivated, self-starter who can work independently once projects are assignedOther duties as assigned.RequirementsBachelor’s Degree.5 years’ experience directly supporting clinical research, QA, or relevant experience in medical/scientific areaExperience conducting audits of vendors and investigative sitesExperience interacting with regulatory authority inspectorsExperience preparing and supporting clinical study sites undergoing regulatory authority inspectionsExperience revising SOPs and proceduresThorough knowledge and application of Good Clinical Practice (GCP) is required, i.e. FDA, ISO 14155, MDR Independent thinking and planning abilityMedical Device experience is preferredAbility to travel up to 30%-40%of time domestically and internationallyExcellent written and verbal communication skillsExceptional teamwork skillsRequires a motivated, self-starter who can work independently once projects are assignedBasic understanding of peripheral and coronary artery disease and therapies preferredKnowledge and experience in supporting device pre- and/or post-market clinical studies is required ACRP or SOCRA certification preferredAbility to work in a fast-paced environment while managing multiple priorities across multiple projectsOperate as a team and/or independently while demonstrating flexibility to changing requirementsMust have excellent verbal and written communication skillsHigh attention to detail and accuracyThe anticipated base pay range for this position is $89,000 to $142,600.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
Vacation – up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
Holiday pay, including Floating Holidays – up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below.
For additional general information on Company benefits, please go to: -https://www.careers.jnj.com/employee-benefits
This job posting is anticipated to close on January 7, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
Johnson Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]
The anticipated base pay range for this position is $89,000 to $142,600.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
Vacation – up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
Holiday pay, including Floating Holidays – up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below.
For additional general information on Company benefits, please go to: -https://www.careers.jnj.com/employee-benefits
This job posting is anticipated to close on January 7, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
Johnson Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]