PQV Combination Product Analyst IV

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Job Description:

The PQV Combination Product Analyst 4 will be responsible for handling high-volume E2E product quality complaint activities and adverse events, including performing Medical Device Reporting (MDR) assessments. Additionally, the Analyst IV Combination Products will provide instruction and feedback to the group as needed and ensure completeness and consistency of complaint and MDR documentation. The position manages and collaborates with business partners and stakeholders (Out Sourced Management Team, Clinical, PV, IT, Local Operating Companies, ESIQ, Call Centers, Brand Protection, External Manufacturing Sites, Internal/External Manufacturing Sites, QA, Business Quality, Medical Safety and R&D) to deliver effective change management, drive process improvements and identify opportunities to improve the accuracy, efficiency and timeliness of the complaint and MDR processes.

This may include risk assessing the impact of proposed changes to the complaint handling/MDR process within and across functional/regional areas and supporting the global change management effectively. The Analyst IV must have the ability to lead projects and communicate effectively with all levels of management as part of stakeholder engagement and change management roll out.

Position duties & responsibilities:

• Perform high-volume end-to-end complaint handling activities, including, but not limited to: Intake, triage and review of the event reported, determination of MDR reportability, recovery of field samples for evaluation, determination of Priority/Non-Priority, and QP notification to LOC. Additional activities include due diligence to be performed with the complainant/intake centers/LOC, trend analysis, defect coding, risk criticality assessment, ensuring accurate/holistic investigation, and review and closure.
• Evaluate complaints to determine if the QTL’s or ULC’s have been exceeded, assess the level of investigation required, and assign to the applicable site for investigation.
• Governance and oversight for daily thru put of complaints and MDR decisions to ensure prioritization and KPI are met.
• Perform MDR evaluations and document written justification to support reportable and non-reportable regulatory decisions.
• Monitor complaints for new malfunction events that may require inclusion in the malfunction description list (MDL).
• Serve as a PQV point person for post market and complaint handling regulatory/MDR questions and inquiries; provides guidance and direction to subordinate Analyst roles and other PQV functions.
• Evaluate information from a technical perspective to ensure appropriate analysis and investigations/ MDR’s are accurately assessed for risk prioritization and performed per procedures, standards, and regulations.
• Back-up Product Quality Vigilance Investigation Support (PQVIS) personnel to support increased volume of complaints.
• Strong collaboration with Global Medical Safety, manufacturing sites, and LOC/BQ for effective complaint handling/MDR assessments and adverse events with potential product quality issues.
• Use technical and product knowledge to provide accurate feedback for escalation/awareness of issues and for current product enhancements/future product development, if applicable.
• Ensure that uniform and timely management of complaint records and regulatory reporting occurs per procedures, standards, and regulations.
• Compile and analyze data, metrics, and trends associated with the complaint handling processes.
• Support internal and external audits and inspections; ability to communicate regulatory and process positions as an SME during regulatory inspections and provide follow-up support as required.
• May interact with regulatory authorities, other J&J operating companies, and J&J global councils to interpret and influence emerging quality systems regulatory trends.
• Provide product workflow leadership to PQV peers to ensure consistent and fully understood End-to-End complaint management process.
• Oversee the PQC complaint monitoring process and analyze the outcome of complaint monitoring.
• For compliance risk events, coordinate and lead the root cause identification, ensuring effective corrective actions for mitigations are captured within QMS documentation (eg CAPA/QI).
• Coordinate and lead the process mapping and change for the development, revision, and/or maintenance of applicable department SOP’s, job aids, and WI’s.
• Works independently, challenges the status quo, identifies gaps, and drives process improvements using Process Excellence tools. Participates and/or leads special projects.
• Executes statistical/data-driven processes and documentation to support controlled risk management and decision making. Exhibits strong ability to collaborate and influence Business Partners to ensure appropriate complaint handling and improved complaint management processes.
• Leads remediation activities and generates the write up and execution of protocols documenting results and report approvals.
• Participates and/or leads special projects. Develop and deliver appropriate training (i.e. process, complaint handling, regulatory reporting) to complaint management system end users.
• Facilitate, lead and collaborate with PQV Reporting and Surveillance on New Product Introduction Processes.
• Interaction with IT partners and application vendors as required.

Professional experience requirements:

• 5+ years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical and/or Medical Device or other related highly regulated industry
• Knowledge of medical safety environment and regulation
• Possesses strong organization skills supporting the ability to prioritize and manage workload and meet performance expectations.
• Strong knowledge of analytical, process mapping, investigation root cause and risk assessment tools
• Global mindset and demonstrated ability to lead change initiatives, project management and develop strong relationships
• Working knowledge of and experience with the following regulatory requirements: 21 CFR parts 4, 820, 803, 806, 210, 211, 314, ICH Q10, GDP, GMP, GVP, ISO 13485:2003, ISO 14971:2007/2012, MEDEV 2.12, CMDR and the Medical Device Directive 93/42/EEC

Educational requirements:

Bachelor’s degree or Master’s degree (preferred) in technical, scientific, or engineering disciplines required. Biomedical Engineer, Registered Nurse, Physician Assistant or similar healthcare provider/science license/certification/degree preferred.

Other requirements:

Location of Role: EMEA

Travel Requirements: This position may require up to 5-10% travel domestically and internationally.

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The anticipated base pay range for this position is:

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.