Quality Manager in GxP

Permanent employee, Full-time · Remote

About P95
P95 finds, collects, analyses and reports epidemiological data to assist public health agencies, research organizations and pharmaceutical companies in improving peoples´ access to safe and effective vaccines.
Our vision is to be the world’s favourite global partner in the field of epidemiological research and pharmacovigilance, in support of vaccine development and use. We are continuously looking for nice, enthusiastic, and smart people.
P95 offers a broad range of services in Epidemiology, Pharmacovigilance, Data Analytics, IT services, Medical Writing and Training.

Job purpose
To support the fast growth of the company, the Quality manager contributes to the development and the maintenance of a robust Quality Management System aligned with regulatory requirements (GCP, GEP, GVP). The Quality manager will work from home anywhere in Europe.
Responsibilities
The roles and 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 (Good Epidemiological Practices): Training, Deviations, CAPAs, change control, risks, management monitoring, lifecycle of Written Standards…
  • Monitoring of Training compliance
  • Writing of SOPs and Policies
  • Development of Quality metrics
  • Perform internal audits/self-inspections
  • Support the company in the preparation and the conduct of external inspections
  • Implementation and follow-up of CAPAs

Experience - the ideal candidate will have
  • Have a Master degree, or PhD, in life Sciences
  • Have minimum 5 years of professional experience in a GxP environment within the pharmaceutical industry, including minimum 3 years in a Quality position
  • Have 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
  • Have the ability to write clear SOPs: English writing skills, flow charts, RACI
  • Have the ability to find the right balance between high Quality Standards and flexibility

Experience - you must also have these skills
  • Having Project Management skills is a plus
  • Having knowledge of MasterControl is a plus
  • Having experience in Vaccine development is a plus.
  • Having a continuous improvement mindset and critical thinking
  • Having high level of personal integrity with a strong commitment to patient welfare and ethical behaviour

Why us?
You will join a young, very dynamic, and fast-growing private research organisation. Our international, passionate, and diverse team consists of 60+ staff including epidemiologists, data scientists, statisticians, data analysts, medical writers, safety and pharmacovigilance specialists, project managers and office support staff spread over more than 10 countries. Our headquarters are in Leuven, Belgium but all our staff work remotely, setting their own time schedule, based on a “getting the job done” mentality. You may need to travel to our head office or to our client’s offices occasionally.
Working at P95 means an opportunity to work in a team on a project basis with ample room for professional development. We offer a lot of autonomy, flexibility and ample opportunities for research and development, to make things happen. We offer the opportunity to learn and evolve professionally. We consequently value self-reliance, initiative, and responsibility of everybody in our team to meet customer expectations.

We offer you a full-time position.

For more information, contact the Head of Quality & Compliance Laurent Delys: laurent.delys@p-95.com

Do you want to join us?
Visit our website www.p-95.com to learn more about who we are and what we do. If you are the one for this job, send your application by filling out the following short form. The call will remain open until the position is filled.
About us
P95 delivers cutting-edge expertise in epidemiology and pharmacovigilance. We are passionate about healthcare and help 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 the pharmaceutical industry, public health institutes, academic institutions, WHO, the European Commission and other governmental organisations and Non-Governmental Organizations (NGOs). Our projects focus mainly on infectious diseases, particularly on vaccines.

P95 Corporate Video.mp4.

We are looking forward to hearing from you!
Thank you for your interest in P95. Please fill out the following short form. Should you have difficulties with the upload of your data, please send an email to jobs@p-95.com

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