Johnson Johnson is recruiting for Clinical Quality Assurance Manager for Shockwave Medical Inc. located in [LOCATION].

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 OverviewThe Clinical Quality Assurance Manager will provide GCP and compliance-related oversight and audit of internal and external Clinical Studies in process, support and update procedure compliance with applicable regulations and oversee clinical affairs initial and ongoing vendor audits as needed. This work is accomplished with minimal 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 Lead on clinical trials by supporting project team compliance with national and international regulatory standards and guidance for medical devicesDevelop audit management plans and audit strategy for ongoing clinical trialsPrioritize audit strategies for GCP programs Coordinate, plan and conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelinesParticipate or lead 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/documentedConduct training for staff (GCP, Inspection Readiness training, etc.)Prepare and support regulatory inspectionsWrite and review/revise Standard Operating Procedure (SOPs)Responsible for initial and ongoing audit of clinical 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 appropriateResponsible to recruit, train, and mentor Clinical Quality resourcesOther duties as assigned.RequirementsBachelor’s degree required.BS degree in scientific field of study is highly preferred but not required.10 years’ experience directly supporting clinical research or relevant experience in medical/scientific area. Minimum 1 year in a role directly managing trials and projects, 2-3 years preferred5 years of experience in Quality in a related industry2 years of people management or relevant experienceExperience conducting audits of vendors and investigative sitesExperience hosting and interacting with regulatory authority inspectorsExperience preparing and supporting clinical study sites undergoing regulatory authority inspectionsExperience authoring and revising SOPs and proceduresThorough knowledge and application of Good Clinical Practice (GCP)i.e. FDA, ISO, MDRKnowledge and experience in supporting device pre- and/or post-market clinical studiesMedical Device experience is preferredAbility to travel up to 30%-40%of time domestically and internationallyExcellent written and verbal communication skillsBasic understanding of peripheral and coronary artery disease and therapies preferredACRP 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 requirementsHigh attention to detail and accuracy

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.

Johnson Johnson is recruiting for Clinical Quality Assurance Manager for Shockwave Medical Inc. located in [LOCATION].

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 OverviewThe Clinical Quality Assurance Manager will provide GCP and compliance-related oversight and audit of internal and external Clinical Studies in process, support and update procedure compliance with applicable regulations and oversee clinical affairs initial and ongoing vendor audits as needed. This work is accomplished with minimal 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 Lead on clinical trials by supporting project team compliance with national and international regulatory standards and guidance for medical devicesDevelop audit management plans and audit strategy for ongoing clinical trialsPrioritize audit strategies for GCP programs Coordinate, plan and conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelinesParticipate or lead 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/documentedConduct training for staff (GCP, Inspection Readiness training, etc.)Prepare and support regulatory inspectionsWrite and review/revise Standard Operating Procedure (SOPs)Responsible for initial and ongoing audit of clinical 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 appropriateResponsible to recruit, train, and mentor Clinical Quality resourcesOther duties as assigned.RequirementsBachelor’s degree required.BS degree in scientific field of study is highly preferred but not required.10 years’ experience directly supporting clinical research or relevant experience in medical/scientific area. Minimum 1 year in a role directly managing trials and projects, 2-3 years preferred5 years of experience in Quality in a related industry2 years of people management or relevant experienceExperience conducting audits of vendors and investigative sitesExperience hosting and interacting with regulatory authority inspectorsExperience preparing and supporting clinical study sites undergoing regulatory authority inspectionsExperience authoring and revising SOPs and proceduresThorough knowledge and application of Good Clinical Practice (GCP)i.e. FDA, ISO, MDRKnowledge and experience in supporting device pre- and/or post-market clinical studiesMedical Device experience is preferredAbility to travel up to 30%-40%of time domestically and internationallyExcellent written and verbal communication skillsBasic understanding of peripheral and coronary artery disease and therapies preferredACRP 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 requirementsHigh attention to detail and accuracy

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.

RequirementsBachelor’s degree required.BS degree in scientific field of study is highly preferred but not required.10 years’ experience directly supporting clinical research or relevant experience in medical/scientific area. Minimum 1 year in a role directly managing trials and projects, 2-3 years preferred5 years of experience in Quality in a related industry2 years of people management or relevant experienceExperience conducting audits of vendors and investigative sitesExperience hosting and interacting with regulatory authority inspectorsExperience preparing and supporting clinical study sites undergoing regulatory authority inspectionsExperience authoring and revising SOPs and proceduresThorough knowledge and application of Good Clinical Practice (GCP)i.e. FDA, ISO, MDRKnowledge and experience in supporting device pre- and/or post-market clinical studiesMedical Device experience is preferredAbility to travel up to 30%-40%of time domestically and internationallyExcellent written and verbal communication skillsBasic understanding of peripheral and coronary artery disease and therapies preferredACRP 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 requirementsHigh attention to detail and accuracy

The anticipated base pay range for this position is 114,000 to 197,800.

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)).This position is eligible to participate in the Company’s long-term incentive program.Employees are eligible for the following time off benefits:Vacation – up to 120 hours per calendar yearSick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar yearHoliday pay, including Floating Holidays – up to 13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar year

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.

RequirementsBachelor’s degree required.BS degree in scientific field of study is highly preferred but not required.10 years’ experience directly supporting clinical research or relevant experience in medical/scientific area. Minimum 1 year in a role directly managing trials and projects, 2-3 years preferred5 years of experience in Quality in a related industry2 years of people management or relevant experienceExperience conducting audits of vendors and investigative sitesExperience hosting and interacting with regulatory authority inspectorsExperience preparing and supporting clinical study sites undergoing regulatory authority inspectionsExperience authoring and revising SOPs and proceduresThorough knowledge and application of Good Clinical Practice (GCP)i.e. FDA, ISO, MDRKnowledge and experience in supporting device pre- and/or post-market clinical studiesMedical Device experience is preferredAbility to travel up to 30%-40%of time domestically and internationallyExcellent written and verbal communication skillsBasic understanding of peripheral and coronary artery disease and therapies preferredACRP 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 requirementsHigh attention to detail and accuracy

The anticipated base pay range for this position is 114,000 to 197,800.

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)).This position is eligible to participate in the Company’s long-term incentive program.Employees are eligible for the following time off benefits:Vacation – up to 120 hours per calendar yearSick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar yearHoliday pay, including Floating Holidays – up to 13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar year

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.