Complaint Vigilance, Analyst 3-00000TV6
Description
Janssen Supply Group, LLC is recruiting for a Complaint Vigilance, Analyst 3 to be based in the Latin America region.
Janssen Pharmaceuticals Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including in oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. Janssen Supply Group, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Janssen Supply Group, LLC is part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provides access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.
The Complaint Vigilance, Analyst 3 is expected to possess detailed knowledge of Janssen products and manufacturing sites to allow for independent triage of product quality complaints in order to execute a thorough complaint assessment in accordance with Standard Operating Procedures while utilizing the Product Quality Management System. This may include but is not limited to, review of the event reported, determination of the defect category, determination of MDR reportability, criticality assessment, determination of investigation needs, recovery of field samples for evaluation (US only), follow-up with complainant (US only), and ensuring timely communication to management when applicable. The individual will exhibit strong ability to collaborate and influence Business Partners (Internal JSC Manufacturing sites, External Business Partners, regional ESIQ organizations, Call Intake Centers, and Global Medical Safety/LSOs, Brand Protection, etc) to ensure appropriate complaint handling and improve complaint management processes. He/she will develop and deliver appropriate training to complaint management system end users. The Analyst 3 will identify and implement complaint process efficiencies. This will include assessing the impact of proposed changes within and across functional areas that impacts the complaint handling process. He/she works independently, challenges the status quo, identifies gaps and drives process improvements using Process Excellence tools, and participates and/or leads special projects.
The Complaint Vigilance, Analyst 3 will process and analyze product complaints according to Policies and Standard Operating Procedures. Evaluate product quality complaints for seriousness, MDR reportability, correctness and consistency of categorization. Assign complaints to appropriate investigational sites. Accurately document and justify if no investigation is deemed necessary in the PQC record. Communication of potential serious PQC’s in a timely manner, as appropriate. Retrieval of field samples (US only), as applicable. Ensure all relevant complaint data is obtained. Partner with customers (JJQS, Internal JSC Manufacturing Sites, External Business Partners, Regional ESIQ organizations, Call Intake Centers, Global Medical Safety/LSOs, Marketing, Sales Administration, Brand Protection, etc) to gain knowledge of products and processes. Participate within and monthly execution of the PQC complaint monitoring process to ensure standard process is followed, and data is consistent and of high quality to assist with correct decision making. Support the compilation of product and site-specific complaint trending data and complaint closure metrics as requested. Support internal and external audits and inspections. Participate within special projects related to complaint management improvements. Develop and deliver training for colleagues and customers on complaint handling process, product specific training, and complaint handling system updates/changes. Partner with customers (JJQS, Internal JSC Manufacturing Sites, External Business Partners, Regional ESIQ organizations, Call Intake Centers, , Local Operating Companies, Global Medical Safety/LSOs, etc) to continuously identify, assess, and improve complaint handling processes. Communicate the value of consistent complaint data to business and provide direct guidance and direction according to complaint management standards and processes. Build consensus across functional areas. Drive technical and process improvements. Influence change. Solicit customer feedback. Execution of the development, revision and/or maintenance of applicable department WI’s and SOPs. Identify, assess, and implement process improvements to the standard process.
Qualifications
A minimum of a BA/BS degree is required, with a preferred discipline in Physical / Life Science or equivalent. An advanced degree is preferred. Project Management PMP is preferred. A minimum of 4+ years’ of related experience including Quality Assurance and/or Quality Control, including experience working in Pharmaceutical, Consumer and/or Medical Device or other highly regulated industry is required. Relevant knowledge on root cause investigations in a production or lab environment is preferred. Experience supporting aspects of the complaint vigilance life cycle for pharmaceutical, device, consumer, and/or cosmetic products is preferred, with a strong preference for those with device and/or pharmaceutical. Knowledge of medical safety environment and regulation is preferred. Strong communication, organizational and project management skills are required. Prior demonstrated success at an Analyst 2 level within J&J, or an equivalent level outside J&J is required.
Must be able to work independently in a global environment and with a virtual team. Must have the ability to lead change initiatives, develop strong effective relationships with key resources and decision makers. Demonstrated knowledge of any of the following is required: manufacturing processes, complaint vigilance global regulatory requirements, including 21CFR parts 210 and 211, ICH Q10 and CFR 820.198. The position requires the ability to support technical teams toward business goals and the ability to allocate and balance competing priorities.
This position may require up to 10% travel, domestic and internationally as needed.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:Latin America-Brazil
Other Locations:Latin America
Organization: JANSSEN SUPPLY GROUP, LLC (6046)
Job Function: Quality Systems
Description
Janssen Supply Group, LLC is recruiting for a Complaint Vigilance, Analyst 3 to be based in the Latin America region.
Janssen Pharmaceuticals Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including in oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. Janssen Supply Group, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Janssen Supply Group, LLC is part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provides access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.
The Complaint Vigilance, Analyst 3 is expected to possess detailed knowledge of Janssen products and manufacturing sites to allow for independent triage of product quality complaints in order to execute a thorough complaint assessment in accordance with Standard Operating Procedures while utilizing the Product Quality Management System. This may include but is not limited to, review of the event reported, determination of the defect category, determination of MDR reportability, criticality assessment, determination of investigation needs, recovery of field samples for evaluation (US only), follow-up with complainant (US only), and ensuring timely communication to management when applicable. The individual will exhibit strong ability to collaborate and influence Business Partners (Internal JSC Manufacturing sites, External Business Partners, regional ESIQ organizations, Call Intake Centers, and Global Medical Safety/LSOs, Brand Protection, etc) to ensure appropriate complaint handling and improve complaint management processes. He/she will develop and deliver appropriate training to complaint management system end users. The Analyst 3 will identify and implement complaint process efficiencies. This will include assessing the impact of proposed changes within and across functional areas that impacts the complaint handling process. He/she works independently, challenges the status quo, identifies gaps and drives process improvements using Process Excellence tools, and participates and/or leads special projects.
The Complaint Vigilance, Analyst 3 will process and analyze product complaints according to Policies and Standard Operating Procedures. Evaluate product quality complaints for seriousness, MDR reportability, correctness and consistency of categorization. Assign complaints to appropriate investigational sites. Accurately document and justify if no investigation is deemed necessary in the PQC record. Communication of potential serious PQC’s in a timely manner, as appropriate. Retrieval of field samples (US only), as applicable. Ensure all relevant complaint data is obtained. Partner with customers (JJQS, Internal JSC Manufacturing Sites, External Business Partners, Regional ESIQ organizations, Call Intake Centers, Global Medical Safety/LSOs, Marketing, Sales Administration, Brand Protection, etc) to gain knowledge of products and processes. Participate within and monthly execution of the PQC complaint monitoring process to ensure standard process is followed, and data is consistent and of high quality to assist with correct decision making. Support the compilation of product and site-specific complaint trending data and complaint closure metrics as requested. Support internal and external audits and inspections. Participate within special projects related to complaint management improvements. Develop and deliver training for colleagues and customers on complaint handling process, product specific training, and complaint handling system updates/changes. Partner with customers (JJQS, Internal JSC Manufacturing Sites, External Business Partners, Regional ESIQ organizations, Call Intake Centers, , Local Operating Companies, Global Medical Safety/LSOs, etc) to continuously identify, assess, and improve complaint handling processes. Communicate the value of consistent complaint data to business and provide direct guidance and direction according to complaint management standards and processes. Build consensus across functional areas. Drive technical and process improvements. Influence change. Solicit customer feedback. Execution of the development, revision and/or maintenance of applicable department WI’s and SOPs. Identify, assess, and implement process improvements to the standard process.
Qualifications
A minimum of a BA/BS degree is required, with a preferred discipline in Physical / Life Science or equivalent. An advanced degree is preferred. Project Management PMP is preferred. A minimum of 4+ years’ of related experience including Quality Assurance and/or Quality Control, including experience working in Pharmaceutical, Consumer and/or Medical Device or other highly regulated industry is required. Relevant knowledge on root cause investigations in a production or lab environment is preferred. Experience supporting aspects of the complaint vigilance life cycle for pharmaceutical, device, consumer, and/or cosmetic products is preferred, with a strong preference for those with device and/or pharmaceutical. Knowledge of medical safety environment and regulation is preferred. Strong communication, organizational and project management skills are required. Prior demonstrated success at an Analyst 2 level within J&J, or an equivalent level outside J&J is required.
Must be able to work independently in a global environment and with a virtual team. Must have the ability to lead change initiatives, develop strong effective relationships with key resources and decision makers. Demonstrated knowledge of any of the following is required: manufacturing processes, complaint vigilance global regulatory requirements, including 21CFR parts 210 and 211, ICH Q10 and CFR 820.198. The position requires the ability to support technical teams toward business goals and the ability to allocate and balance competing priorities.
This position may require up to 10% travel, domestic and internationally as needed.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:Latin America-Brazil
Other Locations:Latin America
Organization: JANSSEN SUPPLY GROUP, LLC (6046)
Job Function: Quality Systems