Quality Manager in Homeoffice bei P95

P95 is a global provider of epidemiology and clinical research solutions with a focus on vaccines and infectious diseases.
We are passionate about healthcare and helping our customers with innovative medical research. We share a sense of urgency with our customers to deliver timely, pragmatic and useful insights to improve healthcare.

Our clients are from the pharmaceutical industry, public health institutes, academic institutions, WHO, the European Commission and other governmental organizations and Non-Governmental Organizations (NGOs). Our projects focus mainly on infectious diseases, particularly on vaccines.

The Quality Manager contributes to the development and the maintenance of a robust Quality Management System aligned with regulatory requirements (GCP, GEP, GVP) and ISO 9001 principles.

The responsibilities for the Quality Manager include, but are not limited to, the following:

• Development and implementation of processes related to a robust Quality Management System according to GCP, GVP and GEP and ISO principles: training, deviations, CAPAs, risk and opportunity, management monitoring, lifecycle of Written Standards, among others.
• Writing of SOPs and Policies.
• Monitoring of Training compliance.
• Development of Quality metrics.
• Perform internal audits/self-inspections.
• Support the company in the preparation and the conduct of external inspections.
• Host audits and Regulatory Authority inspections.
• Implementation and follow-up of CAPAs.

• Master degree, or PhD, in life Sciences
• Minimum 5 years of professional experience in a GxP environment within the pharmaceutical industry, including minimum 3 years in a Quality position
• Good knowledge of GxP principles. Knowledge and experience in working with GEP is a plus.
• Demonstrate ability to design processes adapted to the needs of the business.
• Ability to write clear SOPs: English writing skills, flow charts, RACI.
• Experience in conducting GCP/GVP audits and hosting GCP/GVP audits and Regulatory Authority inspections.
• Have the ability to find the right balance between high Quality Standards and flexibility.
• Project Management skills is a plus.
• Knowledge of MasterControl is a plus.
• Experience in Vaccine development is a plus.
• Continuous improvement mindset and critical thinking.
• High level of personal integrity with a strong commitment to patient welfare and ethical behaviour.

• You have a keen eye for detail and good communication skills
• You can work independently (and remotely) and yet be a great team player
• You have a flexible approach to work
• You are well organized and with attention to detail while keeping a “getting the job done” mentality
• You are client-focused
• You are focused on delivering high-quality results on time
• You are sensitive to cross-cultural differences.

You will join a young, very dynamic, and fast-growing private research organization. Our passionate, truly multicultural, and diverse team of more than 115 colleagues and nearly 40 nationalities include epidemiologists, data scientists, statisticians, data analysts, medical writers, safety and pharmacovigilance specialists, project managers and business support professionals spreading over 20 countries.

We all work remotely, setting our own time schedule, based on a “getting the job done” mentality. This has a positive impact in our work-life balance. Our headquarters are in Leuven (Belgium), but we also have local and regional offices located in Rotterdam (the Netherlands), Bogota (Colombia) and Bangkok (Thailand). You may need to travel occasionally to our Leuven office.

At P95, we are a collaborative and international team that works on diverse projects, topics, and clients and faces interesting challenges. There is a high level of empowerment, flexibility, autonomy as well as opportunities for research and development, to make things happen. We have an open culture of respect and inclusion. Consequently, we value self-reliance, initiative, and responsibility of everyone in our team to meet our internal and external customers’ expectations. Finally, our colleagues experience a strong sense of meaning and purpose driven by the scientific nature and impact of our wo