Job Function:
Quality
Job Sub Function:
Clinical Quality
Job Category:
Professional
All Job Posting Locations:
Irvine, California, United States of America, Jacksonville, Florida, United States of America, Miami, Florida, United States of America
Job Description:
Johnson & Johnson is currently recruiting for a Manager Clinical Quality Risk Management! This position can be located in Irvine, CA, Jacksonville or Miami, FL.
Position Summary:
The Manager, Clinical Quality Risk Management works to support the Clinical Quality Risk Management (CQRM) objectives, overseeing a robust GxP Quality Management System to enable a diverse portfolio of medical device products and services. This individual serves as the clinical quality point of contact to support clinical trial risk assessments, Integrated Quality Plans (IQP), risk mitigations, inspections, and provide guidance to ensure compliance with Good Clinical Practices (GCP), external regulations/requirements, and internal J&J Vision procedures. The Manager is a subject matter expert and acts as a contact for Clinical Research & Development (R&D) functions to internal stakeholders and business partners. The scope of responsibilities for the position will be applicable to the J&J Vision business, which includes J&J Vision Care and J&J Surgical Vision.
MAIN REPONSIBILITIES | DUTIES
Clinical Portfolio Oversight
- Function as a subject matter authority for GCP for J&J Vision and be responsible for supporting, or leading as assigned, quality initiatives.
- Serve as a clinical quality point of contact for inspections, IQP and clinical study / program compliance concerns / escalation.
- Provide clinical quality oversight in support of the J&J Vision MedTech business to ensure compliance with applicable GCP regulatory requirements, J&J Standards, and applicable SOPs.
Risk Management & Governance
- Establish routine presentation of clinical risk and compliance trends and metrics to business partners.
- Develop and manage proactive risk management strategies in coordination with R&D clinical business partners
- Serve as a subject matter expert for Good Clinical Practice (GCP).
Quality Systems & Collaborations
- Support the Vision Quality Management System (QMS) to ensure alignment with the MedTech strategies and policies and evolving industry and regulatory demands related to Good Clinical Practice and Clinical Risk Management.
- Assist the Franchise Head with interdepartmental and cross-functional strategic planning and budget management.
- Support or lead inspection readiness activities, as well as the management of external inspections as needed.
- Collaborate with Clinical R&D to ensure that investigational sites and external service providers supporting J&J Vision clinical studies have appropriate support for the management of third-party inspections.
Qualifications:
Education:
A minimum of a Bachelors or equivalent University degree is required with a focus degree in scientific discipline or business preferred
Skills & Capabilities:
- Five to seven (5-7) years of Clinical research or Clinical quality related experience
- Experience in a medium to large scale, life sciences organization. Medical device/MedTech industry or equivalent healthcare industry experience
- Strong working knowledge of GCP, ISO14155, ICH-GCP, 21CFR Part 11, 21 CFR 812 and other relevant standards and regulations for clinical research.
- Health authority inspection experience is desirable.
- Innovative mindset to build and maintain a competitive advantage
- Conflict resolution, management, and negotiation skills
- Outstanding written and verbal communications skills in English
- Strong project management and execution skills
- Ability to interpret data to develop action plans as part of risk mitigation and / or continuous improvements.
Other:
This position may require up to 10% domestic travel.
Required Skills:
Preferred Skills:
The anticipated base pay range for this position is :
$102,000.00 - $177,100.00
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)).
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
