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PQV Trending & Monitoring Analyst 4

$94k - $151.8k

Johnson & Johnson Innovative Medicine

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function Quality Job Sub Function Customer/Commercial Quality Job Category Professional All Job Posting Locations Horsham, Pennsylvania, United States; Titusville, New Jersey, United States Job Description Johnson & Johnson is currently recruiting for a PQV Trending & Monitoring Analyst 4! This position can be located at any J&J Innovative Medicine site. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s). North America – Requisition #R-083217 EMEA – Requisition #R-085144 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Position Summary The PQV Trending and Insight Analyst 4 performs and leads activities associated with trend analyses, signal detection, complaint data analysis, metrics, and insights within the Product Quality Vigilance organization. This role supports the development and implementation of quality, product-specific surveillance strategies through proactive, customer-focused detection and evaluation of potential signals from emerging trends in complaint data. The position serves as a key interface with product quality owners, quality integrators, manufacturing sites, clinical, product value-stream, medical safety, quality systems, and other business partners to ensure awareness, assessment, and appropriate escalation of complaint signals. The Analyst applies technical, statistical, product, and process knowledge to transform raw complaint and product data into meaningful insights that support risk-based decision‑making, quality improvement, regulatory readiness, and complaint vigilance governance. The PQV Trending Analyst supports individual complaint investigation review, utilizing global visibility to support and coach local sites and will use this vista to lead improvement projects. Key Responsibilities Lead, conduct, and support complaint trending, signal detection, and data analysis activities for product quality complaints across global products and manufacturing sites. Evaluate complaint information from a technical, product, process, and data perspective to ensure appropriate trend analysis, signal evaluation, investigation linkage, and documentation are completed prior to escalation, closure, or governance review. Act as a PQV point of contact for manufacturing sites and cross‑functional business partners on trend insights, signal awareness, aging or coming‑due signal assessments, prioritization, data quality, and complaint analysis needs. Provide guidance, coaching, and support to internal and external business partners on complaint trending expectations, data interpretation, report outputs, and related quality system requirements. Support regulatory inspections, audits, health authority requests, Complaint Vigilance Review Board discussions, business partner requests and senior management reviews by preparing clear data outputs, analyses, explanations, and recommendations. Execute transactional tasks to support the complaint management process (data collection / review, complaint record review, etc.). Lead global, cross‑functional improvement projects. Qualifications Education Bachelor’s degree in a technical, scientific, engineering, statistics, microbiology, data analytics, quality, or related discipline is required; equivalent experience may be considered where applicable. Master’s degree, MBA, or advanced degree in a technical, scientific, engineering, statistics, quality, business analytics, or related discipline is desirable. Green Belt, Six Sigma, CQE, formal investigation training, data analytics certification, or equivalent quality/process improvement certification is preferred. Skills & Capabilities Minimum of 5+ years of related experience, including experience working in pharmaceutical, consumer, medical device, quality assurance, quality control, complaint management, post‑market vigilance, risk management, compliance, or another highly regulated industry. Advanced knowledge and proficiency in Microsoft Excel for data analysis and signal detection, including macros, tables, lookups, and related analytical functions. Experience with signal detection, complaint trending, product quality monitoring, or data‑driven quality surveillance activities is preferred. Experience working with large datasets, complaint systems, quality systems, data processes, dashboards, or technical reporting is preferred. Working knowledge of complaint handling, quality system regulations, and regulated industry expectations, including applicable GMP, GDP, GVP, medical device, pharmaceutical, and combination product requirements, is preferred. Demonstrated ability to communicate effectively verbally and in writing, including technical writing, data storytelling, persuasive communication, and presentations to multiple organizational levels. Global mindset with demonstrated ability to lead change initiatives, manage projects, develop strong relationships, influence without authority, and work independently in a cross‑functional environment. Competencies & Leadership Behaviors Assumes personal ownership and accountability for business results while balancing compliance, risk, innovation, and customer value. Uses sound judgment, analytical thinking, and data‑driven decision‑making to identify issues, evaluate risk, and recommend practical solutions. Seeks to understand emerging trends, technologies, analytical methods, and quality system needs, then applies those insights to improve processes and outcomes. Works independently, challenges the status quo appropriately, and continues to move work forward in the face of ambiguity or uncertainty. Builds trusted partnerships across functions, regions, and levels through clear communication, collaboration, and credible technical expertise. Other Language Requirements: English required; multilingual capability is an asset. Travel Requirements: This position may require up to 0–5% travel domestically and internationally. Environmental Requirements: The incumbent is required to follow all applicable safety procedures to minimize health hazards. Physical/Work Requirements: Working at a computer for extended periods of time; ability to work independently in a global team; ability to attend virtual meetings during off‑business hours and work outside normal working hours when needed. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via Internal employees contact AskGS to be directed to your accommodation resource. Base Pay Range $94,000.00 - $151,800.00 Benefits Vacation – 120 hours per calendar year Sick time – 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year Holiday pay, including Floating Holidays – 13 days per calendar year Work, Personal and Family Time – up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52‑week rolling period 10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time‑Off – 80 hours per calendar year For additional general information on Company benefits, please go to: #J-18808-Ljbffr Johnson & Johnson Innovative Medicine

Vacancy posted 20 hours ago
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