Quality Manager (full-time, remote)

The Quality Manager is responsible for developing, implementing, and maintaining a robust Quality Management System (QMS) in compliance with global and local GxP (good practices) regulatory requirements such as Good Clinical Practices (GCP), Good Epidemiology Practices (GEP), Good Pharmacovigilance Practices (GVP), International Organization for Standardization (ISO) as applicable. This role ensures adherence to quality standards across processes, continuous improvement, and operational excellence.The responsibilities for the Quality Manager include, but are not limited to, the following:

• Independently manage assigned QMS processes, ensuring compliance with regulatory     standards;
• Write and update Written Standards (Policies, Standard Operating Procedures, Guidance, and   Work Instructions);
• Lead monitoring and reporting of training compliance, identifying gaps, and ensuring corrective   actions;
• Manage Quality questionnaires and due diligence activities;
• Develop and oversee the implementation and follow-up of quality and compliance metrics on deviations, corrective and preventive actions, risks and change controls, ensuring timely resolution;
• Conduct internal, site and third-party audits, ensuring compliance and identifying areas for improvement;
• Support the company in external audits and inspections, assisting in document preparation,   audit/inspection hosting and follow-up actions

• Bachelor’s or PhD in Life Sciences;
• 2 to 5 years of experience in a Quality role within a GxP-regulated environment
• Exposure to quality questionnaires and due diligence management
• Ability to write and implement Written Standards (Policies, Standard Operating Procedures,          Guidance, and Work Instructions) process flowcharts, and RACI matrixes
• Exposure to conducting internal audits, third-party audits and supporting external audits and        inspections
• Good understanding of training management, risk management, deviations, corrective actions and preventive actions, and change control handling
• Strong knowledge of GCP, and electronic document, learning, and audit management systems is preferred
• Demonstrated problem-solving abilities and a continuous improvement mindset.
• Computer skills, including proficiency in Microsoft Office programs
• Good understanding of deviation, corrective and preventive action, risk and change control, and  training management principles and ability to support external audits and inspections
• Familiarity with electronic QMS tools and systems
• Demonstrated critical thinking and problem-solving abilities in a Quality setting.

• Analytical thinking;
• Strong collaboration skills to engage with different departments and external partners
• Autonomous problem-solving ability, with minimal supervision required
• Proactively identifies process improvements and suggests efficiency gains
• Comfortable with training and mentoring junior team members.
• Excellent communication and interpersonal skills
• Flexibility and multitasking ability
• Thrive while working under pressure
• Work independently (and remotely) and is a great team player that solves issues in a                 collaborative manner
• Flexible approach to work
• Well organized and plan correctly
• Client-focused
• Focused on delivering high-quality results on time
• 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 nearly 300 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), Accra (Ghana), Nairobi (Kenya), Bangkok (Thailand), Paris (France), Casablanca (Morocco) 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 status, social origin, or condition. We base all our employment decisions on merit, job requirements and business needs.