Company descriptionGerresheimer Moulded Glass is a leading manufacturer of high-quality primary glass packaging solutions for the pharmaceutical, cosmetics, and food and beverage industries. As part of the globally operating Gerresheimer Group, Gerresheimer Moulded Glass offers a comprehensive portfolio of standard and custom hollow glass containers that ensure the protection, safety, and reliability of the packaged products. With a focus on innovation, operational excellence, and sustainability, Gerresheimer Moulded Glass supports its customers in meeting evolving market demands and advancing more sustainable packaging solutions.With seven production sites in Germany, Belgium, Italy and India, Gerresheimer Moulded Glass combines comprehensive manufacturing expertise with a strong international presence and supplies both global and regional customers.Building on a long tradition in glassmaking, Gerresheimer Moulded Glass is committed to providing customer-oriented solutions, creating long-term added value along the entire value chain, and contributing to a more sustainable future.Job descriptionRegulatory Affairs & Compliance: They identify, assess and document relevant legal, regulatory and normative requirements and ensure their transparent communication and effective implementation in the quality management system (QMS).Standards and change management: They monitor changes to regulatory requirements, initiate gap analyses, and, together with the relevant departments, derive suitable measures to ensure compliance.Audit Management: You plan, coordinate, and conduct internal and external audits. You ensure structured follow-up of findings and corrective actions and support the continuous improvement of audit processes.Quality management system: You will further develop our site-wide QMS in close cooperation with the relevant interfaces and promote the sustainable implementation of defined quality standards and processes.Regulatory project support: They support development projects at the component and system level and incorporate regulatory requirements into project planning and implementation at an early stage.Customer and stakeholder management: You are the central point of contact for regulatory questions from our customers and support the processing of corresponding requests as well as the creation and follow-up of Quality Agreements.Technical documentation: They ensure the maintenance, up-to-dateness and traceability of the relevant technical and regulatory documentation.Certification management: You coordinate cooperation with authorities and certification bodies and further develop an efficient, needs-based certification strategy for our Moulded Glass Organisation.Continuous improvement: They identify optimization potential in processes and systems, drive forward suitable improvement measures, and thus make a significant contribution to process safety and product quality.QualificationsThey have a completed Bachelor's or Master's degree in a scientific or technical field or a comparable qualification.They bring in-depth knowledge of international regulatory requirements and relevant standards, ideally in the field of primary packaging, the pharmaceutical industry or the food industry.They have experience in planning, coordinating and conducting internal and external audits, as well as in following up on resulting actions.They have in-depth knowledge of the requirements for quality management systems, especially in the context of ISO 9001, ISO 15378 and ISO 22000.They are familiar with Regulatory Information Management Systems as well as structured approaches to standards, change and documentation management.They impress with their strong analytical and organizational skills, as well as a structured, careful and reliable way of working.They communicate confidently and in a way that is appropriate for the target audience across different hierarchical levels and departments, and they possess a strong customer and solution orientation.They work independently, proactively and reliably, and understand how to win over different stakeholders for common quality and compliance goals.You have excellent written and spoken English skills; additional language skills are an advantage.Additional InformationScope for action: A responsible position with diverse opportunities to actively develop regulatory processes and quality standards.Flexibility: Mobile working is possible within the scope of the tasks. At the same time, regular presence at our international Moulded Glass locations offers the opportunity to directly support processes on-site and implement sustainable improvements.Collaboration on equal terms: Flat hierarchies, short decision-making processes and a high degree of collegiality in an international corporate environment.Professional development: Diverse internal and external training opportunities for professional and personal development.Health and well-being: Corporate health management and a free employee assistance program (EAP).Future planning: Company pension scheme.Additional benefits: company bike leasing via JobRad, attractive discounts with cooperation partners and annual company events.