Job Description
For a world leading Pharmaceutical company were 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 EUGMP guidelines EUGDP 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 GxPrelevant systems used companywide including the qualification and computer system validation of this software.
- Audits and Inspections: Prepare conduct and follow up on selfinspections 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 companys 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 companys quality management department ideally with experience in quality control production or development.
- Regulatory Knowledge: Extensive uptodate 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.
- DecisionMaking: 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.
- ProcessOriented Thinking: Capable of thinking endtoend 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 solutionoriented 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
Required Experience:
Exec