Director, Product Quality Vigilance

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 https://www.jnj.com

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Johnson & Johnson is currently seeking a Director, Quality Product Vigilance, to join our Business Quality team located in Antwerp, Belgium; Schaffhausen, Switzerland; Zug, Switzerland; Cork, Ireland; Milan, Italy; Shaanxi, China; Beijing, China; New South Wales, Australia; South West, Singapore.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United States and Puerto Rico – Requisition Number: R-024355

Japan – Requisition Number: R-025934

Brazil – Requisition Number: R-025936

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.  
The Director, Quality Product Vigilance, will lead a group of associates that provide oversight and processing of global product quality complaints for non-combination Janssen products. The Director role will set clear direction for the complaint execution of the processes (including holistic investigations, and proactive trending) in conformance to current standards and procedures, using applicable system application tools. This role will collaborate within the Janssen organization (including Intake Organizations, Investigational Sites, Global Medical Safety, Product Quality Management) in capturing accurate data, performing investigations as per regulations and proactively interpret data to detect signals. Ensure alignment between country, regional and global processes for overall complaint process. Follow up on metrics to ensure adherence to the standard processes. Ensure appropriate risk management strategies are coordinated. Ensure appropriate metrics/ key performance indicators are defined, measured, and analyzed to ensure process compliance, resource staffing, continuous improvement opportunities and follow up of process execution performance. The Director will identify and address areas of improvement in the complaint process within the team and with key business partner organizations to ensure integrity, consistency, and compliance of the process.

Key Responsibilities:

• Provide oversight of activities associated with end-to-end global complaint handling for non-combo products and measure to complaint timelines
• Direct a team of complaint handling associates which includes INTAKE, INVESTIGATION Outcome, and CLOSURE
• Will be a subject matter expert in product complaint handling
• Review and recommend product actions based on complaint investigation data to include initiation of requests for higher level investigations and communication of product risk
• Review periodic trend analyses of complaint data to monitor product performance and ensure appropriate triggers into CAPAs
• Identify and provide guidance for improvements to the end-to-end Complaint Management Process to ensure the integrity, consistency, and compliance of the process
• Oversee complaint investigation with business partners for products and present complex data to executive staff members
• Ensure timeliness of all complaint handling (triage, outreach, closure) in accordance with procedures, standards, and regulations
• Lead processes and timelines associated with QIs/CAPAs/CCs
• Continuously evaluate effectiveness of the end-to-end process to resolve gaps or areas for improvement; convey results of assessments with appropriate actions to management
• Serve as a subject matter authority 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. Serve as the Complaint Subject Matter Expert during all internal and external audits and inspections
• Work in partnership with Global Medical Safety, Commercial Operation entities (Call Centers, Local Operating Companies, Business Quality, R/D, Regulatory, Investigation Sites, Brand Protection, Legal, Product Quality Management, etc.) in resolving patient issues and developing continuous process improvement initiatives/organizational change
• The Director leads, coaches, and mentors a staff of professionals
   

Qualifications

• Bachelor’s degree or equivalent in technical, life sciences, or engineering field is required
• A Registered Nurse, Physician Assistant, Biomedical Engineer or other related license/certification/degree, or advanced degree in Pharmaceuticals, Regulatory, Quality, Business, etc., is helpful
• A minimum of 10 years of professional experience in pharmaceuticals, medical device, diagnostics, or related field is required
• A proven experience leading of a team responsible for handling product quality complaints, or related-similar activities, is required
• Direct experience with FDA and/or other regulatory audits/inspections is required
• Experience with corresponding to inquiries associated with regulatory agencies is desirable
• Strong knowledge and understanding of regulatory requirements listed below is highly preferred
• Experience/knowledge of most regulations relative to post market surveillance activities and reporting, such as: ISO 9001/13485/14971, FDA Regulations (21 CFR (parts 4, 11, 210, 211, 600, 601, 606, 610, 803, 806, 820 etc.)), ICH Q8, 9 & 10, CMDR, JPAL, and Medical Devices Directive (93/42/eec, 98/79/EC)) is helpful