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 role, you will:

• Provide technical and personnel leadership for a Quality Assurance team of approximately 6 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, contracts, and quality agreements
• Oversee marketing authorization documentation and CTD dossiers
• Ensure validation of computerized systems
• Prepare for, accompany, and follow up on regulatory inspections and customer audits
• Coordinate preparation of management reviews, KPI reports, product quality reviews, and stability reports
• Collaborate closely with the Qualified Person (QP), Supply Chain, Regulatory Affairs, and other departments
• Report directly to executive management

What We're Looking For

• Completed degree in natural sciences or engineering (Pharmacy, Chemistry, Biology, Biochemistry, Biotechnology, Process Engineering) or equivalent extensive professional experience
• Several years of quality assurance experience in a regulated environment, preferably pharmaceutical or medical device industry
• Minimum 3 years of leadership experience managing teams
• Comprehensive knowledge of relevant regulatory frameworks including AMG, AMWHV, GMP/GDP guidelines, and pharmaceutical legislation
• Excellent German language skills (written and spoken) and business-fluent English
• Structured, responsible working style with a solution-oriented approach to challenges
• Strong communication skills with the ability to assert positions and maintain professional presence
• Enthusiasm for dynamic environments and continuous improvement
• Openness to new challenges and strong sense of accountability

How We Work with You

As the recruiting partner for this confidential client, Get A Job.ai manages the entire candidate process. When you apply through our platform at getajob.ai, one of our experienced recruiters will screen your qualifications and conduct an initial interview. If there is a strong match, we will submit your profile to our client for consideration. Please do not contact the employer directly, as all communication is coordinated through our talent team to ensure a professional and confidential process.

Pay

Compensation details will be discussed during the screening process with our recruiting team based on your experience and qualifications.

Equal Employment Opportunity: Get A Job.ai is committed to inclusive hiring practices and works with clients who value diversity. We encourage applications from all qualified candidates regardless of background.