Sr. Manager, Clinical Quality Risk Management Lead

Johnson & Johnson•Cincinnati, OH

2d•$122,000 - $212,750

About The Position

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.

Requirements

BA/BSc or equivalent (Scientific, medical, or related discipline) is 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
Proficiency in Microsoft Office Applications
Available for 25% domestic and international travel

Responsibilities

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.
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)
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
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
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
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

Benefits

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
This position is eligible to participate in the Company’s long-term incentive program.