Lead Plasma Qualification

Your Responsibilities:

• Act as the primary contact for plasma qualification activities both internally and with external regulatory bodies such as the European Medicines Agency (EMA).
• Oversee and lead the plasma qualification process, ensuring adherence to all relevant regulations and quality standards.
• Coordinate with plasma suppliers, quality teams, and internal departments to secure a reliable supply of high-quality plasma.
• Ensure thorough documentation and compliance checks through tools like MasterControl and DocuSign.
• Maintain oversight of the entire plasma supply chain, including collection, transport, storage, and qualification.
• Serve as a strategic leader in aligning our plasma qualification practices with company growth objectives.
• Collaborate with the Quality Systems Group for supplier qualifications, inspections, and audits.

What You Bring:

• A minimum HBO working and thinking level with a background in biochemistry, life sciences, or a related field.
• Extensive experience in quality assurance or regulatory compliance, preferably within the pharmaceutical or biotech industry.
• Knowledge of plasma-specific regulations and handling procedures.
• Strong project management skills with the ability to work collaboratively and manage multiple stakeholders.
• A proactive and analytical mindset, with excellent problem-solving abilities.
• Fluency in Dutch and English.
• Proficiency in quality management systems and regulatory documentation tools.

What We Offer:

• Full-time employment with flexible working hours.
• Salary between € 4.379,34 to € 6.295,238.33%
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• A personal training budget to foster professional growth and development.
• Contribution to travel expenses from the first kilometre.
• Excellent accessibility by public transport, with private parking available.
• A pension plan with Zorg & Welzijn, ensuring financial security for the future.
• A dynamic and supportive working environment with opportunities for professional development, innovation, and impactful work in healthcare.

If this resonates with your career goals and expertise, we’d love to hear from you. Join Prothya Biosolutions and be part of a team dedicated to improving global health through cutting-edge plasma-based solutions.

Acquisitie wordt niet op prijs gesteld. Prothya aanvaardt geen ongevraagde hulp van bureaus voor deze vacature. Toegestuurde cv's (in welke vorm dan ook) door bemiddelingsbureaus aan enige medewerker van Prothya zonder geldige schriftelijke zoekopdracht, worden gezien als eigendom van Prothya waarvoor op geen enkele wijze een vergoeding verschuldigd is.