Global Quality Unit Manager (m/f/x)

From a local pharmacy to an international pharmaceutical company: that's us, Wörwag Pharma.
Our mission: Together for a healty life. We help to prevent and treat diseases of our time. Every day, we are committed to giving everyone the chance to live a healthy life – and have been doing so for more than 50 years!
Would you like to actively support us with this plan? Then apply now, because we are looking for you to start as soon as possible as a

Global Quality Unit Manager (m/f/x)

Your responsibilities

• Assume product responsibility within the Product Compliance Team and ensure compliance of the assigned medicinal products. This includes conformity of manufacture and testing with the marketing authorisation dossier and applicable pharmaceutical and GMP requirements.

• Act as the central interface between Wörwag Pharma, internal manufacturing sites, contract manufacturers and internal functions, and serve as the primary contact for manufacturer-related enquiries and change requests.

• Perform compliance checks; assess and document identified deviations; define, independently implement and follow up appropriate actions.

• Review and approve quality-relevant master documents, including manufacturing and testing instructions, specifications, and packaging instructions.

• Review and approve plans and reports for process validation, analytical method validation and analytical method transfer.

• Manage change controls from preparation of the request and document procurement through the transfer of marketing authorisation-relevant documents and data to contract manufacturers, including coordination of internal and external stakeholders.

• Provide regulatory and pharmaceutical expertise for complex topics and support Regulatory Affairs, for example in preparing responses to deficiency letters.

• Contribute to product development and optimisation projects and technical transfers, including independent responsibility for defined sub-projects.

• Offer analytical support to Product Compliance, Regulatory Affairs, Transfer Project Management and Product Development Teams for development and compliance projects, including risk assessments and scientific or regulatory statements.

• Prepare and review change information, dossier transfers and other data and documentation required by contract manufacturers.

• Further develop the global quality management system by designing and independently implementing improvement measures and preparing global and local SOPs and work instructions.

• Record, evaluate, report and trend relevant KPIs within the area of responsibility and define and implement appropriate improvement measures.

Your profile

• A university degree in natural sciences, pharmacy or a comparable discipline.

• At least five years of professional experience in the pharmaceutical environment, ideally in production, laboratory or Regulatory Compliance at the interface between manufacturing, analytics and marketing authorisation.

• Sound experience in pharmaceutical quality assurance and collaboration with Regulatory Affairs; experience with contract manufacturers is an advantage.

• Strong knowledge of applicable pharmaceutical and regulatory requirements, particularly EU and ICH guidelines, the EU GMP Guide, the German Medicinal Products Act (AMG) and the German Ordinance on the Manufacture of Medicinal Products and Active Substances (AMWHV), and confidence in their practical application.

• Strong analytical capabilities and the ability to assess complex manufacturing, testing and regulatory matters in a structured manner and translate them into robust risk assessments and statements.

• An independent, structured and results-oriented working style, a strong sense of responsibility, and excellent communication and collaboration skills in interdisciplinary and international teams.

• Very good written and spoken German and English.

We are looking forward to receiving your application!