For a world leading Pharmaceutical company, we're currently looking for:

- Global Head QA Systems

Key Responsibilities:

• Develop and Implement Strategic Objectives: Shape and execute the strategic goals for quality management within the corporate group.
• Critical Process Oversight: Identify, define, and monitor essential quality management processes.
• Leadership and Development: Lead and nurture the Quality Management department.
• KPI Management: Define and evaluate relevant KPIs, and implement necessary actions based on these insights.
• Continuous Improvement: Drive the continuous development of quality management processes.
• Regulatory Compliance: Ensure the maintenance of manufacturing and wholesale licenses 
• Quality Management Systems: Establish, maintain, and enhance the quality management system in accordance with EU-GMP guidelines, EU-GDP guidelines, AMG, AMWHV, AMHandelsV, as well as laws and regulations for medical devices, cosmetics, and food products.
• System Selection and Validation: Oversee the selection of GxP-relevant systems used company-wide, including the qualification and computer system validation of this software.
• Audits and Inspections: Prepare, conduct, and follow up on self-inspections and audits with external service providers and during official inspections 
• Regulatory Liaison: Act as the primary point of contact for regulatory authorities.
• Contract Management: Draft, review, and approve responsibility demarcation agreements.
• Support for CSRD/ESG Reporting: Provide key support in the company's CSRD/ESG reporting efforts.

Qualifications and Skills:

• Educational Background: A successfully completed degree in a natural science field related to Life Sciences (e.g., Pharmacy, Biotechnology, Food Technology, etc.).
• Professional Experience: Over 5 years of professional and leadership experience in a pharmaceutical company’s quality management department, ideally with experience in quality control, production, or development.
• Regulatory Knowledge: Extensive, up-to-date knowledge of national and international GxP regulations.
• Preferred Qualifications (not essential): Ideally, certified as a Qualified Person according to §14 AMG, and experience as a Responsible Person for wholesale according to § 2 AMHandelsV, as well as QMB for cosmetics, medical devices, and food products.
• Leadership Style: A modern leader who sustainably develops their team in both technical and leadership career paths.
• Decision-Making: Demonstrates responsibility and makes decisions with consideration for others.
• Teamwork: Enjoys working in interdisciplinary and international teams.
• Communication Skills: Proficient in German and English, both written and verbal, with the ability to clearly and simply convey complex legal and regulatory requirements.
• Process-Oriented Thinking: Capable of thinking end-to-end across the entire value chain, optimizing processes, particularly at interfaces, while keeping the overall outcome in focus.
• Work Ethic: Known for a structured, independent, and solution-oriented working style.
• Business Partner: Sees oneself as a business partner for top management within the corporate group, motivating others by demonstrating the economic benefits of quality awareness.
• Project Management: Experience in managing project

Should you be interested in learning more about this role, please be so kind to contact Robbert Roos at robbert.roos@clearstone-recruiting.de