Purpose & Scope:
The Associate QMS Manager (full-time) works independently or with minimal supervision, and is responsible for implementing operational plans in own region, in support of global Audit and Inspection Readiness and Process Improvement and/or compliance metrics & KPI management and/or the management and/or maintenance of controlled safety documents (e.g.,SOP, WPD); collaborating with relevant GPV and non-GPV the company partners (e.g., Global Clinical and Research Quality Assurance, Global Regulatory Affairs), globally.
Participates in projects related to Audit and Inspection management and Process Improvement, and/or Controlled Document management, and/or Compliance management, representing QMS and taking ownership for specific tasks and deliverables, in order to ensure oversight over, as well as compliance with, all applicable worldwide pharmacovigilance regulations and internal and external KPIs.
Reports to the Global Lead QMS or Process Improvement Team Lead. Is a member of the QMS team and contributes to the development, implementation and successful execution of the GPV mission, objectives and 3-5 year strategic plan.
Essential Job Responsibilities:
Compliance & Key Performance Indicators:
Implement and maintain tools and processes, to identify and monitor compliance and quality metrics for the entire global pharmacovigilance department, PV license partners and vendors for outsourced PV activities.
Ensure continuous monitoring on compliance, timeliness and quality metrics, including detected patterns and trends, in close collaboration with internal (other functions within Global PV and the JP- and EU-QPPVs) and external stakeholders (Regulatory Affairs, Quality Assurance, license partners);
Report on metrics of (outsourced) PV processes, and process related key performance indicators; provide feedback on performance to functional groups on request or proactively in case on non-conformances.
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.
Standards & Quality Documents
Support the maintenance of GPV controlled safety documents (e.g., SOP, WPD) and controlled documents structure, including regional translations, as required; maintains the GPV controlled safety document road map.
Provide support for GPV staff in own region, for writing/ implementing changes to quality documents, ensuring compliance with periodic review of documents, and compliance with applicable SOP writing procedures, templates and style guides.
Collect and coordinate requests for improvement of GPV business processes within the global team, supporting the implementation of new legislation into quality documents.
Assess new or revised SOPs or other applicable quality documents, whether arising within the affiliates or other company functions, or global documents linking in to the Pharmacovigilance system, for impact on GPV.
Facilitate the review and approval process of cross-functional SOPs, and WPDs that involves Global PV workrelated responsibilities. Working closely with colleagues in other departments and within the Global quality network to ensure these processes are reviewed and approved.
Assist with ensuring ready availability/accessibility and understanding of controlled safety documents by all staff.
What we offer
What we offer
Full time (32-40 hours);
Project for 6 months;
Start 01-08-2020 (August);
Good communication skills.
You're fulltime (40 hours) available;
You live in the Netherlands (must);
Must be able to communicate in English (active and passive), other languages considered an asset;
Minimum of 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;
Computer literacy (including Microsoft Office, Access and Project).
About the company
About the company
The company is based in Leiden. You can get there very easily by car and they have parking. You can also reach the company by public transport from The Hague, Amsterdam (Schiphol), Leiden and surrounding areas.
You work in a team with 6 people in total.
1 in USA, 1 in Japan and 4 in The Netherlands.