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 MedicineOur 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.
QualificationsEducation:- 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.
- 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.
Other:- This position may require up to a 5% of domestic and/or international travel.
Required Skills:Preferred Skills: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
The anticipated base pay range for this position is :$102,000.00 - $177,100.00
Additional Description for Pay Transparency:
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)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
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
