Manager, Quality Clinical Risk Mgmt

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 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.

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