Johnson & Johnson Careers
Product Quality Vigilance Supervisor
Requisition ID: 00001EUW
The Product Quality Vigilance (PQV) (Combo or Non-Combo) Supervisor is responsible for the execution and oversight of activities in conformance to current standards and procedures, using applicable system application tools (e.g., Trackwise, Tableau). The Supervisor will oversee a staff of analysts who execute the product quality vigilance process, ensuring timelines are adhered to, manage priorities and escalate risk when necessary to management. This role participates, directly or indirectly, in regional and global product quality vigilance initiatives, and project teams, to develop, consolidate and/or improve Product Quality Vigilance and related/interfacing processes, and supports (PQV) management with internal auditors and external Regulatory Inspections.
The Supervisor oversees coordination and prioritization of the activities of the 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 the evaluation of data and preparation of reports for management and business partners. Collaboration on local, regional and global levels with Call Centers, LOC’s, Medical Safety, Quality (External and Internal sites) and other business partners as required. 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.
- Perform end-to-end complaint handling activities, including but not limited to 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/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 associated GMP compliance requirements. Able to apply this knowledge in combination with quality system requirements 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 to do the same. Ability to provide guidance, collaborate, negotiate, and effectively coach and direct teams and individuals to ensure processes are developed, understood, provide business value, and are adhered to.
- Lead and coach team supporting product quality complaint handling/vigilance, ensuring each member has clearly established goals and objectives, monitors staff performance and having development plans aligned to divisional/Corporate requirements.
- Demonstrated change management in a global virtual environment for stakeholder engagement and effective change roll out.
- Ability to engage and align with other diverse and dispersed organizations and functions. Ability to negotiate, influence and lead without direct line authority. Ability to engage others and lead an organization through continuous improvement and change.
- Identify and Implementation of effective process improvements supporting quality, compliant, and efficient operations.
- Development of procedures, training materials, and other documents necessary to support operations.
- Assessment of severity and impact of a product quality complaint through analysis and interpretation of data, documents, and trends. Data may be gathered from a variety of sources including but not limited to: batch records, certificate of analysis, specifications, lab analyses, packaging, packaging labels, trending reports, investigation reports, complaint threshold reports, and the returned product.
- Determination and implementation of effective CAPAs in addressing complaints.
- Advanced computer skills specifically in Microsoft Word, Excel and PowerPoint.
- Strong technical writing, verbal communication and interpersonal skills.
- Strong problem-solving skills.
PROFESSIONAL EXPERIENCE REQUIREMENTS:
- 5-8 years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceuticals, biologics and/or Medical Device or other related highly regulated industry.
- Knowledge of medical safety environment and regulation.
- Global mindset and demonstrated ability for 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, ISO 13485:2003, ISO 14971:2007/2012, ICH Q10, GDP, GMP, GVP, MEDEV 2.12, CMDR and the Medical Device Directive 93/42/EEC
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.
Travel Requirements: This position may require up to 5-10% travel domestically and internationally.
Environmental Requirements: It is required for the incumbent to follow all safety procedures to minimize health hazards.
Physical/Work Requirements: Working at a computer for extended periods of time. Working independently in a global team. Ability to attend virtual meetings during off-business hours and work outside of normal working hours when needed.
Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-France, Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-Ireland
Janssen Pharmaceutica N.V. (7555)