Quality Manager

Pracovní nabídka

We are looking for an experienced and motivated Site Quality Manager to lead the Quality function at our plasma collection center. This key role ensures that all plasma collected meets the highest standards of safety, quality, and regulatory compliance, in line with European and national legislation, GMP, and Kedrion Group quality standards.

Your Responsibilities

• Manage and oversee all Quality Assurance and Quality Control activities at the plasma collection site
• Ensure compliance with Good Manufacturing Practice (GMP), transfusion medicine principles, and local regulatory requirements
• Supervise and train staff to maintain high professional standards and ongoing quality awareness
• Review and approve deviations, CAPAs, and change controls; ensure timely resolution and documentation.
• Support audits and inspections (internal, external, and regulatory).
• Monitor plasma collection processes, laboratory checks, and plasma release activities.
• Ensure all Standard Operating Procedures (SOPs) are implemented and followed.
• Oversee equipment qualification, calibration, and validation.
• Lead initiatives to align site quality systems with Kedrion’s global standards.
• Prepare and submit quality reports and ensure accurate data reporting to relevant authorities.

What You Bring

• University degree in Medicine, Pharmacy, Biology, Chemistry, or related field (medical qualification an advantage).
• 3–5 years of experience in Quality Assurance or Quality Control in a regulated environment (plasma, blood, or pharma).
• Strong knowledge of GMP and national/EU regulatory frameworks.
• Excellent organizational, leadership, and communication skills.
• Proficiency in Czech and English.
• A proactive, detail-oriented approach and commitment to excellence

What We Offer

• A meaningful role in a company dedicated to producing life-saving therapies.
• Opportunities for professional growth within a global biopharmaceutical network.
• Competitive compensation and benefits.
• A collaborative, ethical, and supportive working environment.