Global Product Quality Vigilance Lead

Company Overview

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 Details

• Job Function: Quality
• Job Sub Function: Quality Assurance
• Job Category: People Leader
• All Job Posting Locations: Beerse, Antwerp, Belgium; Cork, Cork, Ireland; Latina, Italy

Job Description

Johnson & Johnson is currently recruiting for a Product Quality Vigilance (PQV) E2E Supervisor. This position can be located in Horsham, PA, Titusville, NJ, Beerse Belgium, Cork Ireland, or Latina, Italy. The role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. Please note that all job applications will be considered as a single submission.

Position Summary

The Product Quality Vigilance (PQV) Supervisor is responsible for the execution and oversight of activities in conformance with current standards and procedures, using applicable system application tools (e.g., PQMS, Tableau). The Supervisor will oversee a staff of analysts who execute the product quality vigilance process, ensuring timelines are adhered to, manage priorities and escalates risk when necessary to management. This role participates in regional and global product quality vigilance initiatives, project teams, and supports PQV management with internal auditors and external Regulatory Inspections.

The Supervisor oversees coordination and prioritization of activities of team members responsible for PQV process execution, including the management of product quality intake, triage, investigations, issue escalation/management, improvement programs, trending and reporting. The role is responsible for evaluating data and preparing reports for management and business partners. Collaboration occurs at local, regional, and global levels with Call Centers, LOCs, Medical Safety, Quality (External and Internal sites) and other business partners. The Supervisor ensures compliance with corporate policies and procedures, internal requirements and regulatory agency requirements as they relate to Product Quality Vigilance.

This role reports to the Manager, Sr. Manager, Associate Director or Director PQV.

Key Responsibilities

• Perform end‑to‑end complaint handling activities, including intake, triaging, recovery of field samples for evaluation, follow‑up and outreach with complainant / LOC / Call center trend analysis, defect coding, risk criticality assessment, ensuring accurate and holistic investigation, and review and closure.
• Demonstrated knowledge and expertise with other quality systems such as quality Investigations, change control, quality policy standards. Ability to evaluate quality system elements and recommend improvements to meet regulatory requirements.
• Manage initiatives and lead efforts to oversee complex projects, determine and assign resources and individual tasks. Ability to develop and implement simple, yet effective quality systems and metrics.
• Demonstrated understanding of basic manufacturing processes, product knowledge and GMP compliance requirements. Apply this knowledge to lead and develop quality system processes and applications for global patient and healthcare provider needs.
• Support management to allocate and balance resources across competing priorities, identify leveraging opportunities and solutions, and mentor others. Provide guidance, collaboration, negotiation and coaching to ensure processes are developed, understood and provide business value.
• Lead and coach team supporting product quality complaint handling/vigilance, ensuring each member has clearly established goals and objectives, monitors staff performance and has development plans aligned to divisional/CORPORATE requirements.
• Demonstrated change management in a global virtual environment for stakeholder engagement and effective change roll‑out.
• Engage and align with diverse and dispersed organizations and functions. Negotiate, influence and lead without direct line authority to drive continuous improvement and change.
• Identify and implement effective process improvements supporting quality, compliance, and efficient operations.
• Develop procedures, training materials, and other documents necessary to support operations.
• Assess severity and impact of a product quality complaint through analysis and interpretation of data, documents, and trends. Data may be gathered from batch records, certificate of analysis, specifications, lab analyses, packaging, labels, trending reports, investigation reports, complaint threshold reports, and returned product.
• Determine and implement effective CAPAs to address complaints.
• Advanced computer skills in Microsoft Word, Excel and PowerPoint.
• Strong technical writing, verbal communication and interpersonal skills.
• Strong problem‑solving skills.

Qualifications

Education: Bachelor’s degree required; degree in Science, Engineering, Pharmacy or related discipline preferred.

Additional qualifications: Biomedical Engineer, Registered Nurse, Physician Assistant or similar healthcare provider/science license/certification/degree preferred.

Skills & Experience

• 6‑8 years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceuticals, biologics and/or medical device or other highly regulated industry.
• Knowledge of medical safety environment and regulations for pharmaceuticals, devices and/or biologics.
• Global mindset and demonstrated ability for change initiatives, project management and developing strong relationships.
• Working knowledge of more than one of the following regulatory requirements: 21 CFR parts 4, 820, 803, 806, 210, 211, 314, ISO 3485:2003, ISO 14971:2007/2012, ICH Q10, GDP, GMP, GVP, MD 2.12, CMDR and the Medical Device Directive 93/42/EEC.

Other

The position may require up to 10% domestic and international travel.

Salary

The Anticipated Base Pay Range For This Position Is 48,600.00 - 77,395.00.

Benefits

In addition to base pay, we offer an annual bonus with set target (% of pay) depending on pay grade / location, 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, service anniversary and recognition awards. Employees and eligible dependents can participate in several insurance plans. Amounts and actual benefits may vary by location and are subject to change.

EEO Statement

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, contact us via https://www.jnj.com/contact-us/careers. Internal employees may contact AskGS to be directed to your accommodation resource.

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