Complaint Vigilance, Analyst 4-00000T59
Description
Janssen Supply Group, LLC is recruiting for a Complaint Vigilance, Analyst 4 to be based in the Asia Pacific 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 4 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, identify the need for recovery of field samples for evaluation (US only), follow-up with complainant (US only), and ensuring timely communication to management when applicable. He/she will provide product workflow leadership to CCV peers to ensure consistent and fully understood End-to-End complaint management process. The individual will analyze data metrics and trends and document and justify accurately in the PQC record why investigation was not deemed necessary and ensure accurate on time closure or record in the complaint management system. The Complaint Vigilance, Analyst 4 will need to 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 improved complaint management processes. He/she will develop and deliver appropriate training to complaint management system end users, as well as communicate the value of GXP practices and complaint data to the business and provide guidance and direction on complaint management policies, standards and processes. The individual 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. The Analyst 4 works independently, challenges the status quo, identifies gaps and drives process improvements using Process Excellence tools. Participates and/or leads special projects.
The Complaint Vigilance, Analyst 4 will process and analyze product complaints according to Policies and Standard Operating Procedures. He/she will evaluate product quality complaints for seriousness, MDR reportability, correctness and consistency of categorization. The individual will assign complaints to appropriate investigational sites if required; as well as accurately document and justify if no investigation is deemed necessary in the PQC record. The role will provide communication of potential serious PQC’s in a timely manner, as appropriate and ensure all relevant complaint data is obtained. The Complaint Vigilance, Analyst 4 will support peers with daily base business questions and 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. He/she will compile product and site-specific complaint trending data and complaint closure metrics as requested; as well as oversee the PQC complaint monitoring process and analyze the outcome of complaint monitoring. Coordinate necessary corrective actions. The individual will facilitate, lead and collaborate with CCV Reporting and Surveillance on New Product Introduction Processes. The role will support internal and external audits and inspection and participate within and/or facilitate special projects related to complaint management improvements. The Complaint Vigilance, Analyst 4 will develop and deliver training for colleagues and customers on complaint handling process, product specific training, and complaint handling system updates/changes.
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. Process Excellence certification or Project Management PMP is preferred. A minimum of 5+ 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 required, 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 3 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 analyze data and provide consolidated data to management. 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 develop a quality system to meet process and compliance requirements; the ability to make short and medium term decisions within the context of long-term system strategy, and develop system strategy in response to business goals; the ability to drive 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:Asia Pacific
Other Locations:Asia Pacific-Japan, Asia Pacific-China
Organization: JANSSEN SUPPLY GROUP, LLC (6046)
Job Function: Quality Control
Description
Janssen Supply Group, LLC is recruiting for a Complaint Vigilance, Analyst 4 to be based in the Asia Pacific 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 4 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, identify the need for recovery of field samples for evaluation (US only), follow-up with complainant (US only), and ensuring timely communication to management when applicable. He/she will provide product workflow leadership to CCV peers to ensure consistent and fully understood End-to-End complaint management process. The individual will analyze data metrics and trends and document and justify accurately in the PQC record why investigation was not deemed necessary and ensure accurate on time closure or record in the complaint management system. The Complaint Vigilance, Analyst 4 will need to 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 improved complaint management processes. He/she will develop and deliver appropriate training to complaint management system end users, as well as communicate the value of GXP practices and complaint data to the business and provide guidance and direction on complaint management policies, standards and processes. The individual 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. The Analyst 4 works independently, challenges the status quo, identifies gaps and drives process improvements using Process Excellence tools. Participates and/or leads special projects.
The Complaint Vigilance, Analyst 4 will process and analyze product complaints according to Policies and Standard Operating Procedures. He/she will evaluate product quality complaints for seriousness, MDR reportability, correctness and consistency of categorization. The individual will assign complaints to appropriate investigational sites if required; as well as accurately document and justify if no investigation is deemed necessary in the PQC record. The role will provide communication of potential serious PQC’s in a timely manner, as appropriate and ensure all relevant complaint data is obtained. The Complaint Vigilance, Analyst 4 will support peers with daily base business questions and 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. He/she will compile product and site-specific complaint trending data and complaint closure metrics as requested; as well as oversee the PQC complaint monitoring process and analyze the outcome of complaint monitoring. Coordinate necessary corrective actions. The individual will facilitate, lead and collaborate with CCV Reporting and Surveillance on New Product Introduction Processes. The role will support internal and external audits and inspection and participate within and/or facilitate special projects related to complaint management improvements. The Complaint Vigilance, Analyst 4 will develop and deliver training for colleagues and customers on complaint handling process, product specific training, and complaint handling system updates/changes.
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. Process Excellence certification or Project Management PMP is preferred. A minimum of 5+ 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 required, 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 3 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 analyze data and provide consolidated data to management. 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 develop a quality system to meet process and compliance requirements; the ability to make short and medium term decisions within the context of long-term system strategy, and develop system strategy in response to business goals; the ability to drive 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:Asia Pacific
Other Locations:Asia Pacific-Japan, Asia Pacific-China
Organization: JANSSEN SUPPLY GROUP, LLC (6046)
Job Function: Quality Control