Quality Assurance Manager

BioTalent; Dortmund; Vor Ort; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

BioTalent seeks an experienced QA Manager to drive and strengthen the Quality Management System within a regulated life sciences environment. This hands-on role focuses on maintaining compliance, elevating quality standards, and enabling operational excellence across the business.

The ideal candidate will have QA experience in pharmaceutical/biotech/life sciences, strong QMS and GxP knowledge, and proven ability to manage deviations, CAPAs, change controls, and quality investigations, with audit

Qualifikationen

• 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.

Aufgaben

• 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.

Jobbeschreibung

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.