Manager, Quality Clinical Risk Management

6084-Janssen Research & Development Legal Entity•Titusville, PA

7h•$102,000 - $177,100•Onsite

About The Position

Johnson & Johnson is seeking a Manager, Quality Clinical Risk Management for its R&D Clinical Quality team. This independent clinical quality-risk leadership role translates risk signals into proactive mitigation, escalation, inspection and submission readiness, and quality decision support across clinical trials and programs. With minimal direction from the RDQ Director, Clinical Risk Management, the manager owns assigned risks and influences cross-functional teams. The role may be based at a J&J office in Spring House, Pennsylvania; Titusville or Raritan, New Jersey; Horsham, Pennsylvania; High Wycombe, United Kingdom; Beerse, Belgium; Basel, Switzerland; or Madrid, Spain. The manager advises trial teams on identifying and assessing risks in clinical protocols and study setup, reviews mitigation progress with risk owners, maintains risk-monitoring information, and communicates updates through working groups and governance forums. The role also provides issue consultation and escalation, supports corrective and preventative action plans, leads pre-submission quality portfolio review activities, and drives inspection readiness and inspection support. Additional work includes advising on research quality and compliance, supporting quality integration for acquired assets or partners, contributing to quality agreements and divestments, and participating in cross-functional process and tool development. The role works with limited supervision, makes decisions for assigned compounds and studies, and trains and coaches colleagues. The position requires a bachelor’s degree or equivalent in a scientific, medical, or related discipline and at least eight years of healthcare-industry experience. Travel is up to 10%, primarily domestic with some international travel. The anticipated US base pay range is $102,000–$177,100. Eligible employees may participate in retirement and savings plans and the long-term incentive program, and may receive the listed vacation, sick, holiday, personal and family, parental, bereavement, caregiver, volunteer, and other time-off benefits, subject to applicable plan and policy terms.

Requirements

Bachelor’s degree or equivalent in a scientific, medical, or related discipline.
At least 8 years of experience working in the healthcare industry, including the pharmaceutical industry, a contract research organization, and/or a healthcare or hospital system.
Proficiency with Microsoft Office applications.
Proficiency in spoken and written English.
Excellent interpersonal, oral, and written communication skills.
Strong GCP quality and/or clinical-trials experience.
Experience collaborating in a cross-functional team environment.
Flexibility to respond to changing business needs.
Ability to work effectively with culturally diverse styles and business approaches and understand regional and global business structures.

Nice To Haves

Healthcare-industry experience in the pharmaceutical industry and/or a healthcare or hospital system.
Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and/or Good Pharmacovigilance Practice (GPvP).
Experience with clinical-trial risk-management fundamentals.
Global clinical-trial experience.
Experience in a quality function, such as Quality Management, Quality Assurance/Control, or Compliance.
Experience working to ICH guidelines.
Health authority inspection experience, including FDA, EMA, or other inspectorates.
Strong project-planning and project-management skills.
Experience or proficiency with data analytics and/or data visualization tools such as Tableau or Spotfire.
Ability to analyze and interpret collective data to provide insights that support decision-making.
Experience managing escalations and providing CAPA support or advice.
Experience with data science and digital health, including real-world evidence or real-world disease.

Responsibilities

Participate in study activities to identify and assess clinical protocol and study-setup risks and advise clinical team members on mitigation strategies.
Review risk areas with risk owners to assess mitigation progress and risk reduction, and identify new risks or additional mitigation needs for assigned trials or compounds.
Maintain Clinical Quality Plan risk-monitoring information in the quality risk repository.
Lead quality risk-monitoring reviews and coach others on risk monitoring and mitigation reviews.
Communicate and facilitate risk updates to R&D business partners through quality working groups and governance forums, as applicable.
Highlight potential systemic risks to RDQ Clinical Risk Management leadership.
Develop and promote consistent interpretation of issues requiring quality investigations.
Guide significant quality issue management in accordance with corporate standards and escalate significant quality issues to senior R&D management.
Provide initial serious-breach evaluations for quality issues that may require reporting to health authorities.
Advise on the development and implementation of corrective and preventative action plans and effectiveness checks in collaboration with RDQ partners.
Lead cross-functional trial teams and contributors in pre-submission Quality Portfolio Review content development and follow-up; coach others on coordination and management of these activities.
Drive inspection-readiness activities, including development of inspection narratives, preparation of sites of interest, availability of key documents and records, and coordination of mock inspections with Regulatory Compliance teams.
Provide front-room, back-room, and post-inspection support for sponsor-monitor inspections at J&J sites, and inspection support for third parties as contractually agreed.
Provide remote support and post-inspection support for investigational-site inspections.
Supervise or coach others on inspection readiness and support.
Provide independent advice to business partners on research quality and compliance, collaborating with quality professionals and subject-matter experts to ensure consistent interpretation of international regulations and policies.
Support quality integration of acquired assets, companies, or partners, including documentation in program or trial integration plans and execution of assigned responsibilities.
Provide general guidance to stakeholders, contribute to quality agreements with co-development partners as required, and support asset divestment.
Participate in CRM, cross-RDQ, cross-functional, or cross-sector working groups to develop or refine processes, tools, and systems.
Make independent decisions for assigned compounds and studies with limited supervision.
Train and coach peers and new employees as needed.

Benefits

Consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Eligibility to participate in the long-term incentive program.
Vacation: 120 hours per calendar year, subject to policy and date of hire.
Sick time: 40 hours per calendar year, with different amounts for eligible employees in Colorado and Washington.
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, or foster care of a child.
Bereavement leave: up to 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
Caregiver leave: 80 hours in a 52-week rolling period.
Volunteer leave: 32 hours per calendar year.
Military spouse time off: 80 hours per calendar year.