Johnson & Johnson Careers
Director, Business Quality Post Market Surveillance Combination Products, Global
Requisition ID: 4423180618
Janssen Pharmaceuticals, Inc. a member of the J&J Family of Companies, is recruiting for a Director, Business Quality Post Market Surveillance Combination Products, Global to be located in Titusville, NJ or Horsham, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it
The Director, Business Quality Post Market Surveillance Combination Products, Global will provide oversight of activities associated with global complaint handling, Medical Device Reporting for combination products and related activities.
In this role, you will act as a post market regulatory expert that will manage and provide direction globally for combination Product complaint handling unit employees.
Responsibilities include but are not limited to:
- Lead a team of complaint handling analysts as part of the Central Complaint Vigilance (CCV) group.
- Ensure timeliness of all complaint handling and medical device reporting activities in accordance to procedures, standards and regulations.
- Responsible for compliance activities in accordance to the regulations and standards affecting Medical Devices & Pharmaceuticals (e.g. ISO 9001/13485/14971/14001, FDA Regulations (21CFR (210, 2111, 803, 806, 820, part 11, etc.)), ICH Q8, 9 & 10, CMDR, JPAL, and Medical Devices Directive (93/42/eec, 98/79/EC)).
- Oversee the timely filing of malfunctions (i.e. MDR, MDV, MPR, etc.).
- Manage processes and timelines associated with CAPAs.
- Continuously evaluate effectiveness of pertinent post market quality systems to determine gaps or areas for improvement; convey results of assessments with appropriate actions to management.
- Serve as a subject matter expert for regulatory and compliance issues, including regulatory and procedural interpretations, processes such as risk assessment, investigations, medical device reporting and tracking/trending analysis during audits, inspections and assessments by regulatory agencies and corporate bodies.
- Work in partnership with Global Medical Safety, Commercial Operation entities (Call Centers, Local Operating Companies, Business Quality, R/D, Regulatory, Manufacturing, Legal, Quality, etc) in resolving patient issues and developing continuous process improvement initiatives.
- A minimum of a Bachelor’s degree or equivalent in technical, life sciences, or engineering discipline is required.
- A Registered Nurse, Physician Assistant, Biomedical Engineer or other related license/certification/degree is preferred but not mandatory.
- A minimum of 10 years of related experience in a highly regulated environment is required.
- A minimum of 5 years of supervisory experience and leading a team is required.
- Experience managing post market/complaint handling activities is required.
- Direct experience with FDA and/or other regulatory audits/inspections is required.
- Direct experience with corresponding to inquiries associated with regulatory device reporting (i.e. MDR, MDV, etc) is desirable
- Experience managing or performing medical device reporting activities (MDR, MDV, MPR, etc.) is desirable
- Strong knowledge and understanding of regulatory requirements listed below is highly preferred.
- Must have direct experience/knowledge of most regulations relative to post market surveillance activities and reporting, such as: ISO 9001/13485/14971, FDA Regulations (21CFR (210, 211, 803, 806, 820, part 11, part 4, 210, 211, etc.)), ICH Q8, 9 & 10, CMDR, JPAL, and Medical Devices Directive (93/42/eec, 98/79/EC)) is preferred.
- Process excellence or green belt six sigma is preferred.
- This position is located in Titusville, NJ or Horsham, PA and may require up to 20% domestic and international travel depending on business needs.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
North America-United States-New Jersey-Titusville
JANSSEN SUPPLY GROUP, LLC (6046)