Manager Regulatory Affairs and Audit Management (m/w/d)

About the company

Gerresheimer Moulded Glass is a leading manufacturer of high-quality primary glass packaging solutions for the pharmaceutical, cosmetics, as well as food and beverage industries. As part of the globally active 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 changing market requirements and driving more sustainable packaging solutions.

With seven production sites in Germany, Belgium, Italy, and India, Gerresheimer Moulded Glass combines extensive manufacturing expertise with a strong international presence and supplies both global and regional customers.

Building on a long tradition in glass manufacturing, Gerresheimer Moulded Glass is committed to providing customer-oriented solutions, creating long-term value along the entire value chain, and simultaneously contributing to a more sustainable future.

Your tasks

• Regulatory Affairs & Compliance: You identify, assess, and document relevant legal, regulatory, and normative requirements and ensure their transparent communication as well as effective implementation in the Quality Management System (QMS).
• Standards and Change Management: You monitor changes in regulatory requirements, initiate gap analyses, and, together with the relevant departments, derive appropriate measures to ensure compliance.
• Audit Management: You plan, coordinate, and accompany internal and external audits. In doing so, you ensure structured follow-up of findings and corrective actions and support the continuous improvement of audit processes.
• Quality Management System: You further develop our cross-site QMS in close cooperation with the relevant interfaces and promote the sustainable implementation of defined quality standards and processes.
• Regulatory Project Support: You accompany development projects at the component and system levels and integrate regulatory requirements into project planning and implementation at an early stage.
• Customer and Stakeholder Management: You are the central contact person for regulatory questions from our customers and support the processing of corresponding inquiries as well as the creation and follow-up of Quality Agreements.
• Technical Documentation: You 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, demand-oriented certification strategy for our Moulded Glass organization.
• Continuous Improvement: You identify optimization potential in processes and systems, drive appropriate improvement measures, and thus make a significant contribution to process reliability and product quality.

Requirements

• You have a completed Bachelor's or Master's degree in a scientific or technical field or a comparable qualification.
• You bring sound knowledge of international regulatory requirements and relevant standards, ideally in the environment of primary packaging, the pharmaceutical industry, or the food industry.
• You have experience in the planning, coordination, and execution of internal and external audits as well as in the follow-up of resulting measures.
• You have sound knowledge of the requirements for quality management systems, particularly in the context of ISO 9001, ISO 15378, and ISO 22000.
• You are familiar with Regulatory Information Management systems as well as structured approaches to standards, change, and documentation management.
• You impress with strong analytical and organizational skills as well as a structured, careful, and reliable way of working.
• You communicate confidently and appropriately to the target audience across various hierarchical levels and departments and bring a strong customer and solution orientation.
• You work independently, proactively, and reliably, and know how to win different stakeholders for common quality and compliance goals.
• You have very good written and spoken English skills; further language skills are an advantage.

What we offer

• Scope for Design: A responsible position with diverse opportunities to actively further 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 sites offers the opportunity to accompany processes directly on-site and implement sustainable improvements.
• Collaboration at Eye Level: Flat hierarchies, short decision-making paths, and high collegiality in an international corporate environment.
• Development: Diverse internal and external training opportunities for professional and personal development.
• Health and Well-being: Occupational health management and free employee counseling (Employee Assistance Program, EAP).
• Future Provision: Company pension scheme.
• Additional Benefits: Bicycle leasing via JobRad, attractive discounts with cooperation partners, and annual company events.