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BioNTech SE
Biologist-Quality Assurance (m/f/d)
• Mainz, 55131
Teilzeit Homeoffice möglich
Jobticket
Associate Director Systems Quality Assurance Supplier Material Management Mainz, Germany full time Job ID:8922As Associate Director Global QA Supplier Qualification Management, you are part of the Global Supplier Quality team. In this role you will lead the supplier qualification and management team in the clinical and commercial field for biopharmaceutical and gene therapy. You will need to collaborate across different functions within the company and this position requires international work across EU, US and partially also Asian time zones. This is a people leader position, requiring previous successful supervisory experience. Establish global supplier lifecycle
process with stakeholders and manage ongoing changes and compliance Manage all aspects of supplier lifecycle including: onboarding evaluation, monitoring such as auditing and performance, and offboarding Manage internal team members based in US and Germany Establish excellent working relationships and communicate with compliance/ quality groups, vendors, business partners and other functions. Act as a liaison to internal BioNTech stakeholders through all phases of the supplier lifecycle Manage and approve the Approved Supplier List (ASL) and Audit Plan and documented evidence of evaluation records Collaborate globally with GxP supplier groups to standardize practices and migrate data Track and communicate supplier management-specific metrics to management, including but not limited to Quality Management Review Contribute and actively support in migration of documentation of supplier qualification to an electronic system University degree in Chemistry, Pharmacy, Biology, Microbiology,
Engineering or other technical/ scientific area10+ years work experience in an FDA-regulated environment (like manufacturing, quality control or quality assurance) and familiar with Health Authority regulations and guidance Minimum of 5 years experience as people manager. Experience managing global teams is preferred Knowledge of clinical and commercial GMP operations, manufacturing and testing for Cell or Gene Therapy, including Apheresis collection sites Demonstrated a developed knowledge of compliance requirements, and an understanding of current global and regional trends in compliance Demonstrated ability to incorporate risk management fundamentals in the establishment and adherence of audits conducted Excellent English oral, written communication, organizational and interpersonal skills Proven interpersonal skills including good negotiating skills Strong and proven leadership experience and skills (relationship building, adaptability, solution [...]
