As an Associate QMS Manager you will be working independently or with minimal supervision, and will be responsible for implementing operational plans in your own region, in support of global Audit and Inspection Readiness and Process Improvement. You will be collaborating with relevant GPV and non-GPV partners globally within the company (e.g., Global Clinical and Research Quality Assurance, Global Regulatory Affairs). This team acts as a Liaison between Pharmacovigilance and Quality.
The main responsibility of this position is to co-ordinate audit and inspection readiness, following up deviations that come up during inspections, CAPA management and starting up Root Cause Analyses.
Furhtermore you will be supporting in Documentation requests and assure information flow regarding these issues.
Specific tasks include:Inspection / Audit Readiness & Response
- Support GPV and/or local affiliate staff, before, during and after, internal audits and external Health Authority inspections, local affiliate audits, license partners audits and local PV inspections in own region, including onsite support if required (e.g. coordinating pre-audit/inspection requests, provide inspection readiness training etc.).
- Act as a member of inspection operational team taking ownership for specific tasks or deliverables and/ or as a member of the back-office or as scribe during regulatory inspections.
- Coordinate the preparation of audit/inspection responses, and coordinates the preparation of GPV Corrective and preventive action plans and deviations; provide guidance and support to the GPV functions on the administrative process and evidence collection.
- Monitor compliance with timelines for inspection/audit responses, internal commitments and effectiveness checks; escalate risks for delays and need for extensions to QMS management as required.
- Implement best practices in audit / inspections management in close collaborations with regional Quality Assurance functions.
- Conduct trend analysis of aggregated inspection/audit findings to serve continuous improvements, and to avoid repetitive findings.
- Participate as project team member or subject matter expert, in projects to improve regulatory compliance and GPV processes, systems or tools, in close collaboration with functional stakeholders and other QMS team members.
Our client is an international pharmaceutical company with two sites in the Netherlands. The Leiden site is mainly responsible for Pharmacovigilance, Regulatory and Medical activities
As an Associate QMS Manager you will be working in the Global Pharmacovigilance Operations Department and report to the Senior Director Global PV Operations. This Department’s tasks are divided over 4 responsibilities: Compliance & KPIs, Audit Readiness, Process Improvement and Standards & Controlled Documents.
You are a member of the QMS Process Improvement team that consists of 5 people located in the Netherlands, US and Japan.
Functie-eisenWe are looking for candidates with the following qualifications / skill set:
- Minimum BA/BS and at least 4 years in pharmaceutical, biotechnology, or related industry
- Minimum 2 years’ experience in Pharmacovigilance (e.g. in case processing), Regulatory affairs or Safety Quality Assurance, preferably experience in support of the safety quality systems.
- Understanding of safety regulations for both marketed and investigational products, and excellent knowledge of global health authority requirements including ICH, CFR 21, FDAAA, EU GVP module, JP regulations, experience and understanding of Process Management, Standards, Training & IT function as they apply throughout the entire pharmaceutical compound/product life cycle
- Good understanding of PV and Clinical Research processes, and other processes making up the PV system, including the interfaces between these processes.
- Very good understanding of PV, data management and adverse event reporting and processing.
- Excellent oral and written communication skills, ability to interact with all levels of personnel
- Must be able to communicate in English (active and passive), other languages considered an asset
- Computer literacy (including Microsoft Office, Access and Project).
Furthermore you are an independent worker who can stand their ground when necessary. You are able to influence and empower your colleagues. You are quality minded and flexible when it comes to your planning and activities. You are able to remain calm and positive under pressure.
You will be part of a dynamic and accomplished team. We offer an employment of 32 to 40 hours a week with an initial assignment for the duration of 6 months. We provide excellent primary and secondary benefits. Moreover, Modis offers interesting benefits, like participation of our company-fitness-plan. Modis stands for innovation and stimulates new ways of working. Next to a lot of freedom, you will get the necessary amount of responsibilities, combined with the possibility to develop your ambitions and expertise. Together, we can grow.
How to apply
Please tell us who you are and what motivates you! Send us your application using the application button on this website. We expect you to elaborate on your industrial experience in your application letter / phone call.
If you want to learn more about this opportunity, please contact our Recruiters:
Cindy van Gorp on 06-1278 1269
Lars Wijnands on 06-1333 9633