Manager, Quality Clinical Risk Management

Johnson & Johnson Innovative Medicine•Horsham, PA

1d•$102,000 - $177,100•Hybrid

About The Position

Johnson & Johnson is hiring a Manager, Quality Clinical Risk Management for its R&D Clinical Quality Risk Management team. 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. This independent clinical quality-risk leadership position translates risk signals into proactive mitigation, escalation, inspection and submission readiness, and quality decision support across clinical trials and programs. The role owns risk activities hands-on and exerts cross-functional influence, working with limited supervision and making decisions for compounds and studies. The position covers clinical risk management; issue consultation, escalation, and compliance assessment; submission support; inspection readiness and support; quality consultancy; and quality integration for post-licensing, acquisition, and divestment activities. It also contributes to process, tool, and system development through working groups and provides training and coaching to peers and new employees. The role involves up to 10% travel, primarily domestic with some international travel. The required minimum education is a BA/BSc or equivalent in a scientific, medical, or related discipline, and at least eight years of healthcare-industry experience. The anticipated U.S. base pay range is $102,000–$177,100. Eligible employees may participate in the company retirement and savings plans, long-term incentive program, and specified paid time-off and leave benefits, subject to applicable plan and policy terms.

Requirements

BA/BSc or equivalent in a scientific, medical, or related discipline.
At least 8 years of experience working in the healthcare industry, including pharmaceutical industry, contract research organization, and/or healthcare or hospital system experience.
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 across culturally diverse styles and business approaches and understand regional and global business structures.

Nice To Haves

Healthcare-industry experience in pharmaceuticals 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, and/or Compliance.
Experience working to ICH guidelines.
Health Authority inspection experience, including FDA, EMA, and other inspectorates.
Strong project planning and 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 drive 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, identify and assess risks in clinical protocols and study setup, and advise clinical team members on mitigation strategies.
Lead regular reviews with risk owners to assess mitigation progress, risk reduction, emerging risks, and additional mitigation needs for assigned trials or compounds.
Maintain Clinical Quality Plan risk-monitoring information in the quality risk repository.
Independently lead quality risk-monitoring reviews and coach others on monitoring and mitigation reviews.
Communicate and facilitate risk updates to R&D business partners through quality working groups and governance forums.
Escalate potential systemic risks to RDQ Clinical Risk Management leadership.
Promote consistent interpretation of issues requiring quality investigations; guide significant quality issues under corporate standards and escalate them to senior R&D management.
Conduct initial serious-breach evaluations for quality issues that may require reporting to health authorities.
Advise on developing and implementing Corrective and Preventative Action plans and effectiveness checks in collaboration with RDQ partners.
Lead cross-functional trial teams and other contributors in pre-submission Quality Portfolio Review content development and follow-up.
Coach and mentor team members in coordinating and managing Quality Portfolio Review activities.
Drive inspection readiness with trial teams, including developing inspection narratives, preparing sites of interest, ensuring key documents and records are available, and coordinating mock inspections with Regulatory Compliance teams.
Provide front-room, back-room, and post-inspection support for sponsor-monitor inspections at J&J sites, and support third-party inspections as required by contractual agreements.
Provide remote support for investigational-site inspections, including post-inspection support.
Supervise or coach others on inspection readiness and inspection support.
Advise business partners on research quality and compliance questions, collaborating with Quality professionals and subject-matter experts to support consistent interpretation of international regulations and policy.
Support quality integration of acquired assets, companies, or partners; contribute to program or trial 90-day integration plans and complete assigned actions.
Provide general guidance to stakeholders, contribute to Quality Agreements with co-development partners when required, and perform responsibilities under those agreements.
Support and facilitate asset divestment.
Participate in working groups across CRM, RDQ, functions, or sectors to develop or refine processes, tools, and systems.
Provide training and coaching to peers and new employees as needed.

Benefits

Eligibility to participate in the company’s consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Eligibility to participate in the company’s long-term incentive program.
Vacation: 120 hours per calendar year, subject to applicable policy and date of hire.
Sick time: 40 hours per calendar year, with specified higher amounts for employees residing in Colorado or 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.