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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

Job Function:

Quality

Job Sub** **Function:

Clinical Quality

Job Category:

Professional

All Job Posting Locations:

Cincinnati, Ohio, United States of America, Irvine, California, United States of America, Jacksonville, Florida, United States of America, Miami, Florida, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America, Raynham, Massachusetts, United States of America, Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is recruiting for a **Sr. Manager, Clinical Quality Risk Management Lead** at a MedTech site in one of the following locations: **Raritan, NJ** ; **New Brunswick, NJ; Jacksonville, FL; Miami, FL; Cincinnati, OH; Raynham, MA; Santa Clara, CA or Irvine, CA.**

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

The Sr. Manager, Clinical Quality Risk Management Lead for Surgery advances the Clinical Quality Risk Management (CQRM) objective, overseeing a robust GxP Quality Management System to enable a diverse portfolio of medical device health products and services within the Surgery Business. This individual serves as a subject matter expert, providing guidance on compliance-related activities across the business units in Good Clinical Practices (GCP) and/or Good Documentation Practices (GDP). The Sr. Manager, Clinical Quality Risk Management Lead is a trusted advisor to the Business Unit Quality Head and Research & Development (R&D) functions, overseeing the establishment and execution of a Quality Management System (QMS) to ensure compliance of Bioresearch with applicable regulatory requirements, enterprise standards, and company policies and procedures.

The Sr. Manager, Clinical Quality Risk Management Lead oversees the overall clinical quality risk management of the Surgery MedTech Business. They work across teams to ensure the coordination of the identification, assessment, and mitigation of clinical quality risks that could have an impact on trial data integrity, patient rights, safety, or well–being.

Throughout the duration of the clinical program, the Sr. Manager, Clinical Quality Risk Management Lead, oversees the execution of data-driven, risk-based trial and program oversight activities that deliver quality in the execution of clinical trial programs, compliance with regulatory requirements and internal procedures, and that there is a continued state of inspection readiness.

Key Responsibilities:

Risk Management & Governance

Independently, the Sr. Manager, Clinical Quality Risk Management Lead:

+ Ensures CQRM representatives are invited to actively participate in pre-study activities, contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical/cross functional trial team members on effective mitigation strategies.

+ Ensures a consistent clinical quality risk assessment process across the program

+ Provides and leads strategic guidance to CQRM representatives on quality risk assessments, risk entries, and mitigation strategies. If assigned, approves IQP (Integrated Quality Plans) risk monitoring information in quality risk repository to facilitate regular progress reviews

+ Independently drives quality risk monitoring reviews and coaches others on risk monitoring and mitigation reviews

+ Ensures a strategic communication framework with business partners and quality management governance to keep them informed on key quality risks and mitigations.

+ Communicates and facilitates risk updates to Business Unit Business Partners as part of the regular review cycle through Clinical Management Reviews, Quality System Management Reviews, Quality Working Groups and Governance Fora, as applicable.

+ Works with risk owners to develop effective risk mitigation plans to control risks in the trial level IQP

+ Highlight new potential systemic risks to R&D Quality management.

Issue Consultation, Issue Escalation and Compliance Assessment

In consultation with the Head of R&D Quality - MedTech:

+ Develops and ensures a consistent interpretation of issues that require quality investigations

+ Provides guidance for significant quality issues per corporate standards and escalates SQI to senior R&D and Quality & Compliance management.

+ Provides input on quality issues that may require reporting to Health Authorities

+ In collaboration with partners in R&D Quality, provides advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self - Identified, Inspection, Audit)

Submission Support

Inspection Readiness and Support

+ Independently leads key inspection processes and inspection tools to maintain an ongoing inspection readiness with trial teams to develop inspection narratives, identify and prepare sites of interest for inspection (including, pre-inspection visit support), ensure availability of key documents/records and coordinates mock inspection in collaboration with Regulatory Compliance teams

+ Provides front and back room support for Sponsor-Monitor inspections at J&J Sites including post inspection support. Provides inspection support per contractual agreement for third party inspections (vendors, co-development partners and contract research organizations)

+ Provides remote support for investigational site inspections including post inspection support.

+ Provides mentorship and/or coaching for others on inspection support and readiness

Consultancy

+ Provides independent advice on questions related to research quality and compliance from Business Partners in collaboration with other Quality Professionals and Subject Matter Experts to ensure consistent interpretation of international regulations and policy

Post-licensing and Acquisition (L&A) / Integration (where assigned)

With guidance from the head of R&D Quality MedTech or the MedTech Quality & Compliance

+ Supports and leads the coordination of the clinical quality integration of the acquiring asset or company/partner and delivers robust documentation within integration plans and execute assigned responsibilities per plan

+ Provides and leads general guidance to stakeholders

+ As required, provides, and leads input into Quality Agreements with (Co-)development Partners and executes responsibilities per agreement

+ Supports and facilitates asset divestment

Other Duties

+ Supports in an ad hoc or interim manner across Business Units or functional areas as requested by management, including Supplier Quality activities

+ Participates in functional, cross-functional, or cross-sector working groups to develop or refine processes, tools, and systems that deliver innovative quality solutions (as a team member or workstream/project lead)

+ Works with limited supervision, independently making decisions for clinical programs and studies

+ Provides training and coaching to peers and new employees, as needed

Qualifications

Education:

+ BA/BSc or equivalent (Scientific, medical, or related discipline) is required

Experience and Skills:

Required:

+ A minimum of 10 years of experience working in the healthcare or regulated industry (MedTech, pharmaceutical industry, contract research organization and/or healthcare/hospital system, health authority, etc.)

+ Excellent interpersonal, oral, and written communication skills

+ Proven strong Good Clinical Practices quality and/or clinical trials experience

+ Experience collaborating in a cross-functional team environment

+ Flexibility to respond to changing business needs

+ Demonstrates ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures

Other:

+ Proficiency in Microsoft Office Applications

+ Available for 25% domestic and international travel

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . Internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Budget Management, Clinical Research and Regulations, Clinical Trials Operations, Collaborating, Compliance Management, Consulting, Fact-Based Decision Making, Mentorship, Organizing, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Risk Compliance, Safety-Oriented, Standard Operating Procedure (SOP), Tactical Planning, Technical Credibility, Vendor Selection

The anticipated base pay range for this position is :

$122,000.00 - $212,750.00

For Bay Area:

$142,000.00 - $244,950.00

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

Pay Transparency - PG 40

• The expected base pay range for this position, in the Bay Area, is

• The expected base pay range for this position is

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