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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-timeTettau, 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, the pharmaceutical industry, or the food industry.
  • 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 and a structured, careful, and reliable working approach.
  • Ability to communicate confidently and appropriately across hierarchy levels and departments, with a customer- and solution-oriented approach.
  • Ability to work independently, proactively, and reliably, and to engage stakeholders in shared quality and compliance goals.
  • Very good spoken and written English; additional language skills are advantageous.

Responsibilities

  • Identify, assess, and document relevant legal, regulatory, and normative requirements, communicate them transparently, and ensure their effective implementation in the quality management system.
  • Monitor changes to regulatory requirements, initiate gap analyses, and develop appropriate compliance measures with relevant departments.
  • 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 stakeholders and promote sustained implementation of defined quality standards and processes.
  • Support development projects at component and system level by integrating regulatory requirements early into planning and implementation.
  • Serve as the central contact for customers on regulatory matters, support related inquiries, and prepare and follow up on Quality Agreements.
  • Maintain relevant technical and regulatory documentation to ensure it is current and traceable.
  • Coordinate collaboration with authorities and certification bodies and further develop an efficient, fit-for-purpose certification strategy for the Moulded Glass organization.
  • Identify process and system improvement opportunities and advance suitable improvements to support process reliability and product quality.

Desired Qualifications

  • Experience with 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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