lead, manage and develop the Supply Chain Compliance team to ensure full compliance with regulations and standards, including but not limited to GxP.
monitor SCM activities from a compliance perspective.
orchestrate the necessary alignment and communication between QA and SCM.
ensure a governance for Safety, Health & Environment measures, including Business Continuity.
ensure compliance by leading and developing the SCM Compliance team, always up to date with changes in relevant regulations and adaptation of best practices close to the business needs.
coordinate and timely execute quality related measures, including deviations, changes and corrective/preventive actions.
create and manage training documents (e.g. SOP, WI).
support in qualification and validation activities for SCM related processes, material, equipment, rooms, software and service Partners.
ensure audit readiness, preparation and participation as SPOC.
support with projects, product launches, claims and execution of risk analysis, while implementing globally aligned standards and utilizing BioNTech’s eQMS and other relevant systems.
Requirements
Bachelor's degree in a related field, with a focus on Compliance or Quality. Master's degree preferred.
Minimum of 5 years of Compliance experience in Supply Chain Management, Logistics, or Manufacturing environments, with at least 3 years in a leadership role
In-depth understanding of GxP (GMP, GDP) processes and compliance standards
Excellent communication and interpersonal skills, with the ability to build strong relationships with stakeholders at all levels
Strong analytical and problem-solving skills, able to identify and resolve complex issues
Hands-on mentality with ownership of tasks, seeing them through to completion.
Ability to work independently within general conditions such as budget and project milestones.
Fluency in German and English, both oral and written.