Associate Director Systems Quality Assurance Supplier & Material Management
Mainz, Germany | full time | Job ID:8922
As 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 area
10+ 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 oriented, empathetic, critical thinking)
Travel will be required up to 30%
It's our priority to support you:
Your flexibility: flexible hours | vacation account
Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
Your health and lifestyle: Company bike
Your mobility: Job ticket | Deutschlandticket
Your life phases: Employer-funded pension | Childcare