Manager, ICSR Compliance

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:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

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

We are searching for the best talent for a Manager, ICSR Compliance to be located in Horsham, PA; Raritan, NJ or Titusville, NJ.

Purpose:

The Manager, ICSR Compliance is responsible for leading Pharmacovigilance (PV) compliance oversight activities related to Individual Case Safety Report (ICSR) regulatory reporting and associated compliance monitoring processes. This role ensures timely identification, investigation, and remediation of compliance risks impacting ICSR reporting obligations and drives continuous improvement through data-driven insights, trend analysis, and proactive risk management.

The Manager partners with cross-functional stakeholders across Medical Safety, Regulatory Affairs, Clinical, and Vendors to monitor compliance performance, investigate deviations, implement Corrective and Preventive Actions (CAPAs), and support regulatory inspections and internal audits.

Keys for success in this role include the ability to develop collaborative partnerships with stakeholders / business partners of all levels, influence without authority, resolve complex issues independently, and determine when escalation to senior management is appropriate.

Key Responsibilities:

• Lead oversight of global ICSR reporting compliance against regulatory requirements and internal procedures.

• Monitor compliance metrics, performance indicators, thresholds, and key risk indicators.

• Identify emerging compliance risks, trends, and recurring issues impacting reporting obligations.

• Ensure compliance monitoring activities are conducted in accordance with global Standard Operating Procedures (SOPs) and regulatory requirements.

• Oversee investigations of late ICSR submissions and other compliance deviations.

• Ensure root cause analyses are completed accurately and consistently.

• Partner with functional areas to develop and implement corrective and preventive actions.

• Monitor CAPA effectiveness and verify sustainable resolution of identified issues.

• Analyze compliance data and performance trends.

• Develop compliance reports and executive summaries for leadership review.

• Provide actionable insights to support risk-based decision-making and continuous improvement initiatives.

• Support the development and validation of compliance metrics and reporting processes.

• Lead and develop direct reports.

• Establish individual goals and development plans. Foster a culture of accountability, compliance excellence, continuous improvement, and employee engagement.

• Coordinate responses to compliance-related observations, findings, and regulatory inquiries.

• Maintain documentation and evidence supporting compliance oversight activities.

Qualifications

Education:

• A minimum f a Bachelor’s degree is required

Experience/Skills:

Required:

• A minimum of 6 years of pharmaceutical industry experience
• A minimum of 5 years of pharmacovigilance, drug safety, or compliance experience
• Minimum 2 years of direct people management experience, including performance management, coaching, development planning, and workload prioritization.
• Experience with ICSR case processing, regulatory reporting, or PV compliance monitoring.
• Experience conducting investigations, root cause analysis, and CAPA management.
• Previous people leadership or team lead experience.
• Strong knowledge of global pharmacovigilance regulations and reporting requirements.
• Understanding of GxP, quality systems, audit, and inspection processes.
• Experience interpreting compliance metrics and trends.
• Strong analytical and problem-solving skills.

…