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.
• 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 PDQ complaint monitoring process to ensure standard process is followed, and data is consistent and of high quality to assist with correct decision making.
• 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.
• Develop and deliver training for colleagues and customers on complaint handling process, product specific training, and complaint handling system updates/changes.
BUSINESS RELATIONS:
• Partner with customers (JJQS, Internal JSC Manufacturing Sites, External Business Partners, Regional ESIQ organizations, Call Intake Centers, Global Medical Safety/LSOs, etc) to continuously identify, assess, and improve complaint handling processes.
Communicate the value of consistent complain data to business and provide direct guidance and direction according to complain management standards and processes
• Build consensus across functional areas
• Drive technical and process improvements. Influence change.
• Solicit customer feedback.
DOCUMENTATION:
• 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.
RELATED EXPERIENCE :
DESCRIBE THE TYPES OF EXPERIENCE AND TYPICAL NUMBER OF YEARS REQUIRED FOR THIS ROLE:
• 4+ years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical and/or Medical Device or other related or highly regulated industry.
• Preferred experience supporting many/all aspects of the complaint vigilance life cycle for pharmaceutical, device, and/or cosmetic products. Device and pharmaceutical strongly preferred.
• knowledge of medical safety environment and regulation
• Strong communication, organizational and project management skills.
• Prior demonstrated success at Analyst 2 level or equivalent.
LIST JOB SPECIFIC COMPETENCIES/SKILLS REQUIRED:
1. Can work independently in a global environment/virtual team
2. Global mindset
3. Ability to lead change initiatives, develop strong effective relationships with key resources and decision makers.
4. Demonstrated knowledge and expertise of manufacturing processes, complaint vigilance global regulatory requirements, including 21CFR parts 210 and 211, ICH Q10 and CFR 820.198.
5. Ability to support technical teams toward business goals.
6. Ability to allocate and balance competing priorities
7. Competency in understanding system functionality in relation to process requirements.
8. Fluent in English, ability to travel internationally as needed. Ability to work outside of normal working hours when needed.
9. Leadership Competencies: .
Education:
BA/BS - Required
MA/MA/MBA – Desirable
Subject or Major:
Physical / Life Science (Equivalent experience is acceptable)
Certification:
Project Management PMP – Desirable