Quality Manager (remote (EU Based), full-time)

at  P95

EXPERIENCE - THE IDEAL CANDIDATE WILL HAVE

• 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.

EXPERIENCE - YOU MUST ALSO HAVE THESE SKILLS

• 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.

ABOUT US

P95, an Ampersand portfolio company, is a global provider of clinical and epidemiological services related to vaccines and infectious diseases.
Founded in 2011, we are a leader in sourcing, analyzing, and reporting epidemiological data to assist health agencies and pharmaceutical companies in improving access to safe and effective vaccines.
Headquartered in Belgium, P95 has also offices in Europe, North America, South America, South Africa, and SE Asia.
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

JOB PURPOSE

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.

RESPONSIBILITIES

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.