Permanent Position · Lead

Head of Quality Assurance

A leading organization in a regulated industry is seeking a Head of Quality Assurance to lead a team of approximately six employees. This role involves the strategic development and continuous improvement of the Quality Management System (QMS) to ensure regulatory compliance and operational efficiency. The successful candidate will be responsible for overseeing core QMS processes and ensuring adherence to relevant industry standards. This position requires close collaboration with internal departments and external partners to maintain high-quality standards.

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Opportunity overview

Opportunity type
Permanent Position
Required seniority
Lead
Work location
Hybrid, Remote
Location
Germany
Start
ASAP
Duration
Permanent
Travel
—

Required skills

Quality Management System (QMS)Regulatory ComplianceGMP/GDPDocument ManagementDeviation ManagementCAPA ManagementRisk ManagementChange Control ManagementSupplier QualificationComputerized System ValidationAudits and Inspections

Required industry experience

Life Sciences & PharmaMedical Devices

Responsibilities

  • Lead and manage a QA team of approximately 6 employees.
  • Develop and improve the Quality Management System (QMS) for regulatory compliance and efficiency.
  • Ensure adherence to GMP/GDP and relevant national regulations.
  • Manage core QMS processes: document, deviation, CAPA, risk, and change control management.
  • Oversee supplier and service provider qualification, and contract/quality agreement management.
  • Manage regulatory submission documents (e.g., AmRadV, CTD dossiers).
  • Ensure validation of computerized systems.
  • Prepare for and manage authority inspections and customer audits.

Requirements

  • Completed scientific or engineering degree (e.g., pharmacy, chemistry, biology) or equivalent experience.
  • Several years of professional experience in quality assurance within a regulated environment.
  • Minimum of three years of leadership experience.
  • Profound knowledge of relevant regulations (e.g., AMG, AMWHV, GMP/GDP guidelines).
  • Excellent German and business-fluent English language skills.
  • Structured, responsible, and solution-oriented work approach.
  • Strong communication skills, assertiveness, and confident demeanor.
  • Enthusiasm for a dynamic environment and continuous change.