Head of Quality Assurance (m/w/d)

Responsibilities

We are representing a confidential pharmaceutical organization seeking a Head of Quality Assurance to lead their quality operations in Köln. In this senior leadership role, you will:

• Provide technical and disciplinary leadership for a Quality Assurance team of approximately 10 professionals
• Drive continuous development of the Quality Management System (QMS) to ensure regulatory compliance and operational efficiency
• Ensure adherence to GMP/GDP requirements and relevant pharmaceutical regulations
• Oversee core QMS processes including document management, deviation handling, CAPA, risk management, change control, complaints, recalls, and self-inspections
• Manage supplier and service provider qualification systems along with contract and quality agreement processes
• Oversee regulatory submission documentation and dossier management
• Ensure validation of computerized systems across the organization
• Lead preparation for, participation in, and follow-up activities related to regulatory inspections and customer audits
• Coordinate reporting activities including management reviews, KPI reports, product quality reviews, and stability reports
• Collaborate closely with the Qualified Person (QP), Supply Chain, Regulatory Affairs, and sister companies
• Report directly to executive leadership

What We're Looking For

Our client requires a seasoned quality professional with:

• Completed degree in natural sciences or engineering (Pharmacy, Chemistry, Biology, Biochemistry, Biotechnology, Process Engineering) or extensive professional experience in equivalent fields
• Several years of experience in quality assurance within a regulated environment, preferably pharmaceutical or medical device industries
• Minimum of three years of leadership experience managing teams
• Deep knowledge of relevant regulatory frameworks (pharmaceutical law, GMP/GDP guidelines, and related regulations)
• Excellent German language skills (written and spoken) and fluent English proficiency
• Structured, responsible working style with a solution-oriented approach to challenges
• Strong communication skills with the ability to influence and present confidently to stakeholders
• Enthusiasm for dynamic environments and continuous improvement initiatives
• Accountability and openness to new challenges

How We Work with You

Get A Job.ai serves as the exclusive recruiting partner for this confidential pharmaceutical client. When you apply through our platform at getajob.ai, one of our specialized recruiters will screen your qualifications and experience. If there is a strong match, we will submit your profile to our client for consideration. Please do not attempt to contact the hiring organization directly, as all communication must flow through our talent team to maintain the confidentiality of this search.

Pay

Compensation details will be discussed during the screening process with our recruiting team.

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