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

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Johnson & Johnson is hiring a Senior Manager, Clinical Quality Assurance, to join our team! This is a fully remote role, with flexibility to be based anywhere within a reasonable commute to a major airport.

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. Manager, Clinical Quality Assurance 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 Functions

• Act as a Clinical Quality Lead on clinical trials by supporting project team compliance with national and international regulatory standards and guidance for medical devices
• Develop and manage audit management plans and audit strategy for ongoing clinical trials
• Prioritize 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) guidelines
• Participate or lead 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
• Conduct training for staff (GCP, Inspection Readiness training, etc.)
• Prepare and support regulatory inspections
• Write 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 needed
• Identifies and escalates site, vendor and study related issues to management, as appropriate
• Responsible to determine appropriate Clinical Quality resourcing, and then recruit, train, and mentor necessary Clinical Quality resources
• Provide oversight and mentoring to Clinical Project Management resources to ensure appropriate tracking of budgets, timelines and resourcing for clinical trials
• Other duties as assigned.

Qualifications

• Bachelor’s Degree or equivalent experience in a scientific field of study
• 12 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 preferred
• 5+ years of experience in Quality in a related industry
• 3+ years of people management or relevant experience
• Experience conducting audits of vendors and investigative sites
• Experience hosting and interacting with regulatory authority inspectors
• Experience preparing and supporting clinical study sites undergoing regulatory authority inspections
• Experience authoring and revising SOPs and procedures
• Thorough knowledge and application of Good Clinical Practice (GCP) i.e. FDA, ISO, MDR
• Knowledge and experience in supporting device pre- and/or post-market clinical studies
• Medical Device experience is preferred
• Ability to travel up to 30%-40% of time domestically and internationally
• Excellent written and verbal communication skills
• Basic understanding of peripheral and coronary artery disease and therapies preferred
• 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
• High attention to detail and accuracy

The anticipated salary range for this position is $138K - $207K

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 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.

https: //www.careers.jnj.com/employee-benefits

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.