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Gerresheimer

Global supplier of pharma packaging solutions

Manager Regulatory Affairs and Audit Management

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeEssen, GermanyNo salary listed

About the Job

Requirements

  • A completed bachelor's or master's degree in a natural science or technical field, or a comparable qualification.
  • Strong knowledge of international regulatory requirements and relevant standards, ideally in primary packaging, pharmaceutical, or food industries.
  • Experience planning, coordinating, and conducting internal and external audits and following up on resulting actions.
  • Strong knowledge of quality management system requirements, particularly ISO 9001, ISO 15378, and ISO 22000.
  • Familiarity with Regulatory Information Management systems and structured approaches to standards, change, and documentation management.
  • Strong analytical and organizational abilities, with a structured, careful, and reliable work style.
  • Ability to communicate confidently and appropriately across hierarchy levels and departments, with customer and solution orientation.
  • Ability to work independently, proactively, and reliably, and to engage diverse stakeholders toward shared quality and compliance goals.
  • Very good spoken and written English; additional language skills are an advantage.

Responsibilities

  • Identify, assess, and document relevant legal, regulatory, and normative requirements, and ensure their transparent communication and effective implementation in the quality management system.
  • Monitor changes in regulatory requirements, initiate gap analyses, and work with relevant departments to define appropriate compliance measures.
  • Plan, coordinate, and support internal and external audits; ensure structured follow-up of findings and corrective actions; and support continuous improvement of audit processes.
  • Develop the cross-site quality management system in close collaboration with relevant interfaces and promote sustained implementation of defined quality standards and processes.
  • Support development projects at component and system level, incorporating regulatory requirements early in project planning and execution.
  • Act as the central contact for customers on regulatory matters, support responses to related inquiries, and prepare and follow up on Quality Agreements.
  • Ensure relevant technical and regulatory documentation is maintained, current, and traceable.
  • Coordinate collaboration with authorities and certification bodies, and develop an efficient, needs-based certification strategy for the Moulded Glass organization.
  • Identify process and system optimization opportunities and drive improvement measures that contribute to process reliability and product quality.

Desired Qualifications

  • Knowledge of regulatory requirements and standards in primary packaging, the pharmaceutical industry, or the food industry.
  • Additional language skills.

About the Company

Gerresheimer

Global supplier of pharma packaging solutions

Gerresheimer creates specialized packaging and drug delivery devices for the pharmaceutical and biotech industries. Its offerings include packaging solutions and device components for medicines, such as inhalers and insulin pens, as well as complex drug delivery systems. The company works by designing, engineering, and manufacturing these components to meet strict pharma quality and regulatory standards, serving as a global partner to pharma and biotech customers. It differentiates itself by shifting from consumer glass products to focused, high-spec packaging and device solutions for pharma and cosmetics, building its business around close collaboration with customers and end-to-end support. The goal is to help pharmaceutical and biotech companies bring safe, reliable, and scalable packaging and delivery technologies to market across the globe.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Düsseldorf, Germany
Founded
1864

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