Manager Global Quality Assurance CSV
BioNTech SE · Mainz, Rheinland-Pfalz, DE
Mainz, Germany | full time | Job ID: 11236 About the Role: As part of the global QA team, this role is responsible to support the validation of global comput...
Job description
Mainz, Germany | full time | Job ID: 11236 About the Role: As part of the global QA team, this role is responsible to support the validation of global computerized system in the BioNTech network. Your Contribution: - You will support global validation projects of from a QA perspective to ensure that corporate computerized systems are validated and meet BioNTech's quality system and current regulatory requirements - You will oversee pharmaceutical quality system processes (e.g., CAPA, deviation, change control, training) for corporate GxP-critical applications, IT infrastructure, and projects, ensuring effective collaboration between global and local levels - You will support the development, harmonization, optimization, and maintenance of CSV-related quality processes globally and across multiple manufacturing sites and areas, including Global Standards/Policies and SOPs, ensuring compliance with applicable regulatory requirements - You will contribute to audit and inspection readiness within your area of responsibility, presenting global QA oversight and validation activities and processes during inspections A Good Match: - You hold a degree in pharmacy, chemistry, biology, or a r...