Manager, Quality Clinical Risk Management

Job Function:
Quality

Job Sub Function:
Clinical Quality

Job Category:
Professional

All Job Posting Locations:
Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently seeking a Manager, Quality Clinical Risk Management to join our R&D Quality CRM team located at a J&J office in Spring House, PA; Titusville, NJ; Raritan, NJ; Horsham, PA: High Wycombe, UK: Beerse, Belgium; Basel, Switzerland, and Madrid, Spain.

This is a position in R&D Clinical Quality. This Manager role is an independent clinical quality-risk leadership position responsible for translating risk signals into proactive mitigation, escalation, inspection/submission readiness, and quality decision support across trials and programs. The role combines hands-on risk ownership with significant cross-functional influence

With minimal direction from the RDQ Dir, Clinical Risk Management:
• Risk Management:

• Actively participates all study activities, contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical team members on effective mitigation strategies.

• Leads regular review of risk areas in collaboration with Risk Owners, to evaluate progress of risk mitigations and risk reduction, and to identify potential new risks or additional mitigation needs (trial and/or compound, as assigned).
• Maintains CQP (Clinical 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
• Communicates and facilitates risk updates to R&D Business Partners as part of the regular review cycle through Quality Working Groups and Governance Fora, as applicable (trial and/or compound, as assigned).
• Highlight new potential systemic risk to RDQ CRM management.

Issue Consultation, Issue Escalation, and Compliance Assessment:

• Develops and ensures a consistent interpretation of issues that require quality

investigations
• Provides guidance for significant quality issues (SQI) per corporate standards and

escalates SQI to senior R&D management.
• Provides initial serious breach evaluation of quality issue that may require reporting

to Health Authorities
• In collaboration with partners in RDQ, provides advice on the development and

implementation of Corrective and Preventative Action (CAPA) Plans and

Effectiveness Checks (Self - Identified, Inspection, Audit)

Submission Support:

• Pre-submission Quality Portfolio Review (QPR)

• Leads the Cross-Functional Trial Team and other key contributors in QPR content

development & follow-up Activities
• Coaches and mentors other team members on QPR for coordination and

management of activities

Inspection Readiness and Support
• Drives ongoing inspection readiness activities with trial teams to develop inspection

narratives, identify and prepare sites of interest for inspection (including, preinspection

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. Provide 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 supervision 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:

• With the guidance from the CRM L&A Team and Therapeutic Area Head or Delegate:

• Support the coordination of the quality integration of the acquiring asset or

company/partner and deliver robust documentation within the program/trial

integration plans (90-day plan) and execute assigned responsibilities per plan.
• Provide general guidance to stakeholders
• As required, provide input into Quality Agreements with (Co-)development Partners

and execute responsibilities per agreement.
• Supports and facilitates asset divestment

Other activities:

• Participates in CRM, cross-RDQ J&J, 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 compounds and studies
• Provides training and coaching to peers and new employees, as needed

• Required Minimum Education: BA/BSc or equivalent (Scientific, medical, or related discipline)
• Required Years of Related Experience: A minimum of 8 years of experience working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) required

Required Knowledge, Skills and Abilities:
• Proficiency in Microsoft Office Applications
• Proficiency in speaking and writing English
• Excellent interpersonal, oral, and written communication skills
• Proven strong GCP 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

Percentage Traveled:

Up to 10% (Primarily domestic travel with some international travel)

Preferred Related Industry Experience: Healthcare industry (pharmaceutical industry and/or

healthcare/hospital system)

Preferred Knowledge, Skills and Abilities:
• Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GPvP)
• Experience with fundamentals of clinical trial risk management
• Global clinical trial experience
• Experience working in a Quality function (Quality Management, Quality Assurance/Control and / or Compliance)
• Experience working to ICH guidelines
• Health Authority Inspection experience (FDA, EMA and other inspectorates)
• Strong Project Planning/Management skills
• Experience and/or proficiency with data analytics and/or data visualization tools (i.e., Tableau, Spotfire, or related)
• Proven ability to analyze & interpret collective data to provide insights to drive decision-making
• Experience in managing escalations and CAPA support/advisement
• Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease)

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)).

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