Pharmacovigilance QA EMEA Auditor

Position overview

Within the Pharmacovigilance (PV) QA team of BioResearch Quality & compliance (BRQC) there is an exciting opportunity to join the team as a (Sr.) Specialist PV Auditor. This role will deliver on PV audits across the PV system in Janssen and even collaborate on audits across sectors. This role is key to deliver high quality audits across EMEA, utilizing new audit strategies, and provide new insights based on audit experience for consideration in continuous improvement of the audit approach. In every audit we do, we maintain a good work life balance for the team. The successful applicant will interact with their team of peers (3-6), and several key business partners within BRQC and outside of BRQC e.g. (International PV, Business Quality, Global Regulatory Affairs). It offers an opportunity for a wide view across all aspects of a fully functional PV system in Janssen, and our interactions with other pharmaceutical companies, service providers and distributors across EMEA. If you have the PV expertise and want to help in ensuring and verifying the robustness of the approach across the region, this is an ideal opportunity.

Tasks & Responsibilities:

• Independently leads the planning, conduct and reporting of Bio Research Quality Assurance routine and non-routine audits of activities, data, internal facilities and processes in GxP (key domain will be Pharmacovigilance) to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope. May support other auditors in planning, conduct and reporting of audits.
• Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.
• Provides expertise and knowledge to less experienced auditors, Business Partners and the core business sector on quality and compliance processes/procedures. Interprets and applies regulations/ policies to issues of moderate complexity, when required.
• Takes an active role in projects as assigned by supervisor and interacts with key stakeholders as appropriate.
• Meets priorities, checkpoints and timelines for all aspects of work and projects to achieve adequate progress
• Participates in regulatory inspections in core and supporting roles
• Apply and execute innovative BRQC QA audit methodologies focusing on reaching deeper quality and compliance insights.
• Ensures personal compliance with training at all times and may contribute/build training materials as needed, for training and/or coaching

Qualifications

Qualifications & Experience

• Demonstrated audit experience as PV auditor
• Expert level of Pharmacovigilance knowledge with the ability to provide critical information, advice and guidance on complex quality and compliance issues.
• Approximately 3-8 years of experience in the pharmaceutical industry within PV.
• Excellent communication and collaboration skills
• Fluent in English

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Primary Location
Belgium-Antwerp-Beerse-
Other Locations
Europe/Middle East/Africa-Spain-Community of Madrid-Madrid, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-France-Haute-de-Seine-Issy Les Moulineaux, Europe/Middle East/Africa-Switzerland-Allschwil
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
Quality
Requisition ID
2105980241W