Complaint Vigilance, Analyst 4-00000O5C
Description
POSITION SUMARY
The Complaint Vigilance, Analyst 4 is expected to:
- Posses detailed knowledge of JSC 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, criticality assessment, recovery of field samples for evaluation (US only), follow-up with complainant (US only), and ensuring timely communication to management when applicable.
- Provide product workflow leadership to CCV peers to ensure consistent and fully understood End-to-End complaint management process.
- 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.
- Develop and deliver appropriate training to complaint management system end users.
- Communicate the value of GXP practices and complaint data to the business and provide guidance and direction on complaint management policies, standards and processes.
- 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.
- Works independently, challenges the status quo, identifies gaps and drives process improvements using Process Excellence tools. Participates and/or leads special projects.
KEY ACCOUNTABILITIES
COMPLAINT MANAGEMENT:
- Process and analyze product complaints according to Policies and Standard Operating Procedures.
- Evaluate product quality complaints for seriousness, correctness and consistency of categorization.
- Assign complaints to appropriate investigational sites.
- 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.
- Supports peers with daily base business questions.
- 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.
- Facilitate and participate within process of auditing Complaint Records to ensure standard process is followed, and data is consistent and of high quality to assist with correct decision making and provides constructive feedback to the organization towards improvements.
- Compile product and site-specific complaint trending data and complaint closure metrics as requested.
- Support internal and external audits and inspections.
- Participate within and/or facilitate special projects.
BUSINESS RELATIONS:
- Actively manage customer relationships (JJQS, Internal JSC Manufacturing Sites, External Business Partners, Regional ESIQ organizations, Call Intake Centers, Global Medical Safety/LSOs, etc).
- Communicate the value of consistent complaint data to business and provide direct guidance and direction according to complaint management standards and processes.
- Partner with customers to continuously identify, assess, and improve complaint handling processes.
- Build consensus across functional areas.
- Drive technical and process improvements. Influence change.
- Solicit customer feedback.
DOCUMENTATION:
- Create, revise and maintain applicable department WI’s and SOPs.
- Identify, assess, and implement process improvements to the standard process.
- Develop and deliver training for colleagues and customers on complaint handling process, product specific training, and complaint handling system updates/changes.
EXTERNAL AND INTERNAL INTERACTIONS
- Expected to analyze data, regulation, processes and other trends, and present/report to management. Will interact with Directors, of plant sites across all areas of Janssen Supply Chain.
- May interact with regulatory authorities;, other J&J operating companies, and J&J global councils to interpret and influence emerging quality systems regulatory trends.
- Interacts with product quality complaint handling, manufacturing and quality personnel at internal manufacturing sites across J&J family and external partners.
- Interacts with safety and surveillance personnel at Global Medical Safety (GMS) for investigation of adverse events with potential product quality issues.
- Provides support for internal audits and inspections by regulatory authorities.
- Can expect to interact with site and business leaders across JSC and across J&J. Interaction with IT partners and application vendors can also be expected.
STEP-BE
Qualifications
RELATED EXPERIENCE:
- Master education and about 5+ years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical and/or Medical Device or other related of highly regulated industry or
- Bachelor education and about 10-12 years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical and/or Medical Device or other related of highly regulated industry
- Relevant knowledge on root cause investigations (production, lab environment)
- Knowledge of medical safety environment and regulation
- Strong communication, organizational and project management skills.
- Prior demonstrated success at Analyst 3 level or equivalent.
COMPETENCY REQUIREMENTS:
- Strong interdependent partnering skills, interpersonal communication, influencing skills.
- Can work independently in a global environment/virtual team.
- Global mindset.
- Ability to lead change initiatives, develop strong effective relationships with key resources and decision makers.
- Ability to analyze data and provide consolidated data to management.
- Demonstrated knowledge and expertise of manufacturing processes, complaint vigilance global regulatory requirements, including 21CFR parts 210 and 211, ICH Q10 and CFR 820.198.
- Ability to develop a quality system to meet process and compliance requirements. 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.
- Ability to drive technical teams toward business goals.
- Ability to allocate and balance competing priorities.
- Competency in understanding system functionality in relation to process requirements.
- Fluent in English, ability to travel internationally as needed. Ability to work outside of normal working hours when needed.
- Ability to guide, collaborate, negotiate, and effectively coach and direct others to ensure processes are developed, understood, provide business value, and are adhered to.
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: Quality Systems
Description
POSITION SUMARY
The Complaint Vigilance, Analyst 4 is expected to:
- Posses detailed knowledge of JSC 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, criticality assessment, recovery of field samples for evaluation (US only), follow-up with complainant (US only), and ensuring timely communication to management when applicable.
- Provide product workflow leadership to CCV peers to ensure consistent and fully understood End-to-End complaint management process.
- 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.
- Develop and deliver appropriate training to complaint management system end users.
- Communicate the value of GXP practices and complaint data to the business and provide guidance and direction on complaint management policies, standards and processes.
- 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.
- Works independently, challenges the status quo, identifies gaps and drives process improvements using Process Excellence tools. Participates and/or leads special projects.
KEY ACCOUNTABILITIES
COMPLAINT MANAGEMENT:
- Process and analyze product complaints according to Policies and Standard Operating Procedures.
- Evaluate product quality complaints for seriousness, correctness and consistency of categorization.
- Assign complaints to appropriate investigational sites.
- 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.
- Supports peers with daily base business questions.
- 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.
- Facilitate and participate within process of auditing Complaint Records to ensure standard process is followed, and data is consistent and of high quality to assist with correct decision making and provides constructive feedback to the organization towards improvements.
- Compile product and site-specific complaint trending data and complaint closure metrics as requested.
- Support internal and external audits and inspections.
- Participate within and/or facilitate special projects.
BUSINESS RELATIONS:
- Actively manage customer relationships (JJQS, Internal JSC Manufacturing Sites, External Business Partners, Regional ESIQ organizations, Call Intake Centers, Global Medical Safety/LSOs, etc).
- Communicate the value of consistent complaint data to business and provide direct guidance and direction according to complaint management standards and processes.
- Partner with customers to continuously identify, assess, and improve complaint handling processes.
- Build consensus across functional areas.
- Drive technical and process improvements. Influence change.
- Solicit customer feedback.
DOCUMENTATION:
- Create, revise and maintain applicable department WI’s and SOPs.
- Identify, assess, and implement process improvements to the standard process.
- Develop and deliver training for colleagues and customers on complaint handling process, product specific training, and complaint handling system updates/changes.
EXTERNAL AND INTERNAL INTERACTIONS
- Expected to analyze data, regulation, processes and other trends, and present/report to management. Will interact with Directors, of plant sites across all areas of Janssen Supply Chain.
- May interact with regulatory authorities;, other J&J operating companies, and J&J global councils to interpret and influence emerging quality systems regulatory trends.
- Interacts with product quality complaint handling, manufacturing and quality personnel at internal manufacturing sites across J&J family and external partners.
- Interacts with safety and surveillance personnel at Global Medical Safety (GMS) for investigation of adverse events with potential product quality issues.
- Provides support for internal audits and inspections by regulatory authorities.
- Can expect to interact with site and business leaders across JSC and across J&J. Interaction with IT partners and application vendors can also be expected.
STEP-BE
Qualifications
RELATED EXPERIENCE:
- Master education and about 5+ years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical and/or Medical Device or other related of highly regulated industry or
- Bachelor education and about 10-12 years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical and/or Medical Device or other related of highly regulated industry
- Relevant knowledge on root cause investigations (production, lab environment)
- Knowledge of medical safety environment and regulation
- Strong communication, organizational and project management skills.
- Prior demonstrated success at Analyst 3 level or equivalent.
COMPETENCY REQUIREMENTS:
- Strong interdependent partnering skills, interpersonal communication, influencing skills.
- Can work independently in a global environment/virtual team.
- Global mindset.
- Ability to lead change initiatives, develop strong effective relationships with key resources and decision makers.
- Ability to analyze data and provide consolidated data to management.
- Demonstrated knowledge and expertise of manufacturing processes, complaint vigilance global regulatory requirements, including 21CFR parts 210 and 211, ICH Q10 and CFR 820.198.
- Ability to develop a quality system to meet process and compliance requirements. 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.
- Ability to drive technical teams toward business goals.
- Ability to allocate and balance competing priorities.
- Competency in understanding system functionality in relation to process requirements.
- Fluent in English, ability to travel internationally as needed. Ability to work outside of normal working hours when needed.
- Ability to guide, collaborate, negotiate, and effectively coach and direct others to ensure processes are developed, understood, provide business value, and are adhered to.
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: Quality Systems