Manager, Quality Clinical Risk Management

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

• US- Requisition Number: R-106260
• UK - Requisition Number: R-106893
• Belgium - Requisition Number: R-106896
• Spain- Requisition Number: R-106903
• Switzerland - Requisition Number: R-106912

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

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 Suppor t

• 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)

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:

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