Quality Assurance Manager

Quality Assurance Manager

Dortmund Vollzeit Kein Homeoffice möglich
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Our client is seeking an experienced QA Manager to support and continuously improve their Quality Management System within a regulated life sciences environment. This is a hands-on quality role focused on ensuring compliance, driving quality standards, and supporting operational excellence across the business.

Key Responsibilities

  • Maintain, develop, and continuously improve the Quality Management System (QMS).
  • Create, review, update, and manage quality documentation and procedures.
  • Manage deviations, change controls, CAPAs, and associated investigations through to completion.
  • Plan, coordinate, and monitor quality training activities across the organisation.
  • Support qualification and validation activities, ensuring compliance with internal and regulatory requirements.
  • Review analytical testing documentation and quality records.
  • Prepare for and participate in customer, regulatory, and internal audits and inspections.
  • Support audit findings, corrective actions, and continuous improvement initiatives.

Requirements

  • Experience working within Quality Assurance in a regulated pharmaceutical, biotech, CRO, CDMO, or life sciences environment.
  • Strong knowledge of Quality Management Systems and GxP requirements.
  • Experience managing deviations, CAPAs, change controls, and quality investigations.
  • Audit preparation and inspection readiness experience.
  • Excellent organisational, communication, and stakeholder management skills.
  • Ability to work independently and manage multiple quality priorities.

This is an excellent opportunity to join a growing life sciences organisation and play a key role in maintaining quality and compliance standards across the business.

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Kontaktdaten:

BioTalent Recruiting-Team