Quality Manager (remote (EU Based), full-time) in Home Office bei P95

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 7 years of professional experience in a GxP environment within the pharmaceutical industry, including minimum 5 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.
• Fluent French speaking is a plus.
• 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.
• Knowledge of Learning Management Systems 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 200 colleagues and nearly 40 nationalities include epidemiologists, clinical operations, CRAs, CTAs, 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), Johannesburg (South Africa), Bangkok (Thailand), Paris (France) and Durham (United States). You may need to travel occasionally.

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 work.

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.
P95 is an Equal Opportunities Employer. The company is committed to equal employment opportunities regardless of age, sexual orientation, gender, pregnancy, religion or belief, union belief, wealth, birth, nationality, ethnic origin, disability, medical history, skin color, marital status, genetic information, parental sta