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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

Job Function:

Quality

Job Sub** **Function:

Customer/Commercial Quality

Job Category:

People Leader

All Job Posting Locations:

Guaynabo, Puerto Rico, United States of America, Gurabo, Puerto Rico, United States of America, Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Somerset, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently seeking a Director, Quality Product Vigilance, to join our Business Quality team located in Horsham, PA; Titusville, NJ; Somerset, NJ; Raritan, NJ; Gurabo, PR; or Guaynabo, PR.

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):

Belgium, Switzerland, Italy, Ireland, Singapore, China, Australia - Requisition Number: R-025932

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

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, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$146,000-$251,850

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. 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)). This position is eligible to participate in the Company’s long-term incentive program. 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 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 Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits Co-Ops and Intern Positions: Co-Ops/Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the plan. Co-Ops and Interns are eligible for the following sick time benefits: up to 40 hours per calendar year; for employees who reside in the State of Washington, up to 56 hours per calendar year Co-Ops and Interns are eligible to participate in the Company’s consolidated retirement plan (pension) Positions Represented by CBA: This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.