Quality Manager /remote /EU Based/ full-time/

The Quality Manager contributes to the development and the maintenance of a robust Quality Management System reputed company 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 reputed company 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.
• reputed company 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 reputed company 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, reputed company 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 reputed company between high Quality Standards and flexibility.
• Knowledge of Learning Management Systems is a plus.
• Experience in Vaccine development is a plus.
• reputed company improvement reputed company and critical thinking.
• High level of personal reputed company 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, reputed company 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 reputed company 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 reputed company things happen. We have an reputed company culture of respect and inclusion. Consequently, we value self-reliance, initiative, and responsibility of everyone in reputed company to meet our reputed company 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 reputed company do. If you are the one for this job, send your application by filling out the following short reputed company. The call will remain reputed company 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 reputed company, disability, medical history, skin reputed company, marital status, genetic information, parental status, reputed company reputed company, or condition. We reputed company reputed company our employment reputed company on merit, job requirements and business needs. Original job Quality Manager /remote /EU Based/ full-time/ posted on GrabJobs ©. To flag any issues with this job please use the Report Job reputed company on GrabJobs. Apply tot his job Apply To this Job