Manager, ICSR Compliance
Johnson & Johnson Co.
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Job summary
Johnson & Johnson is seeking a Manager, ICSR Compliance to lead pharmacovigilance compliance oversight for global ICSR reporting in a matrix environment. The role partners with Medical Safety, Regulatory Affairs, Clinical teams and Vendors to ensure timely investigations, CAPAs, and regulatory readiness across Horsham, PA; Raritan, NJ; and Titusville, NJ.
You will develop metrics, produce executive summaries, monitor KPIs, and drive continuous improvement while mentoring direct reports and
Qualifications
- Minimum 6 years in pharmaceutical industry.
- Minimum 5 years PV, drug safety, or compliance experience.
- Minimum 2 years of direct people management experience.
- Experience with ICSR case processing and regulatory reporting.
- Experience investigations, root cause analysis, and CAPA management.
- Previous people leadership in a global matrix environment.
- Strong knowledge of global pharmacovigilance regulations and reporting requirements.
- Excellent communication with senior leadership.
Responsibilities
- Lead global ICSR reporting compliance.
- Monitor compliance metrics and KPIs.
- Identify emerging compliance risks and trends.
- Ensure SOP and regulatory alignment.
- Oversee investigations of late ICSR submissions.
- Conduct root cause analyses and CAPA management.
- Develop corrective and preventive actions with stakeholders.
- Monitor CAPA effectiveness and ensure sustainable resolution.
- Analyze compliance data and trends.
- Prepare executive compliance reports.
- Provide actionable risk-based insights.
- Develop compliance metrics and reporting processes.
- Lead and develop direct reports.
- Set goals and development plans.
- Coordinate responses to observations and inquiries.
- Maintain documentation and evidence.
Skills
Education
Tools
Job description
Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America
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.
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.
- 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.
- A minimum f a Bachelor’s degree is 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.
- Ability to communicate effectively with senior leadership and cross-functional stakeholders.
- Experience working in a global matrix environment.
- Strong project management and organizational skills.
- Proficiency with PV systems, reporting tools, dashboards, and data analytics platforms.
- This position may require up to a 5% of domestic and/or international travel.
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.
If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.
Compliance Management, Corrective and Preventive Action (CAPA), Cross-Functional Collaboration, Developing Others, Fact-Based Decision Making, Give Feedback, Good Manufacturing Practices (GMP), Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Risk Assessments, Standard Operating Procedure (SOP), Tactical Thinking, Team Management
$102,000.00 - $177,100.00
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)).
- 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
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