Vice President

Strategic Quality Leadership

• Develop and implement global quality strategies aligned with company objectives.

• Ensure compliance with cGMP, FDA, EMA, and other international regulatory requirements.

• Establish strict quality standards for sterile manufacturing environments, including aseptic processing and contamination control.

• Act as speaking partner for regulatory agencies for audits, inspections, and certifications.

• Ensure compliance with national and international regulatory requirements as applicable for Pharmaceuticals and Nutrition for Fresenius Kabi (such as EU GMP, 21CFR Part 210/211 and Part 4, Chinese GMP, Pharmacopeias).

Quality Management & Compliance

• Oversee risk management strategies related to contamination prevention, validation, and environmental monitoring.

• Ensure compliance with regulatory guidelines, including FDA 21 CFR Part 211, CFR Part 4, ICH Q9, ICH Q10, and pharmacopoeia standards (USP, EP, JP).

• Support quality investigations for deviations, CAPAs, and field safety corrective actions, ensuring timely resolution.

• Develop and manage quality policies and SOPs, ensuring alignment with best practices.

Manufacturing & Operational Excellence

• Partner with manufacturing, engineering, and supply chain teams to optimize sterile production efficiency.

• Implement process validation and continuous improvement initiatives to enhance quality.

• Support lean manufacturing and Six Sigma principles to optimize quality assurance mechanisms.

• Establish robust training programs to educate staff on aseptic techniques and compliance standards.

• Support of overarching QA & QC efficiency programs to contribute to Fresenius Kabi's target for affordable medicines and services.

• Being responsible for the budget allocated to these functions.

• Planning, performance and assessment of internal quality audits.

People & Leadership Development

• Lead and mentor a high-performing quality management and compliance team.

• Foster a culture of continuous improvement, accountability, and excellence.

• Guide executive leadership on quality trends, risks, and innovations within the industry.

• Advanced degree in Pharmacy, Microbiology, Chemistry, Engineering, or related field

• 15+ years of experience in quality management and/or operational functions within sterile pharmaceutical manufacturing, as well as significant manufacturing quality experience with progressive challenging QA/QC leadership in pharmaceutical or related industry

• Excellent expertise in cGMP, FDA, EMA, ICH guidelines, and aseptic processing regulations

• Excellent knowledge in pharmaceutical technology to produce sterile products (SVPs, LVPs) including aseptic manufacturing

• Strong leadership, strategic thinking, and problem-solving abilities

• Enhanced expertise in interpretation of GxP regulations

• Active experience with US-FDA and EU-authority inspections

• Understanding of key financial and operating indicators for pharmaceutical companies

• Accomplished quality leader with relevant experience in injectable, aseptic pharmaceutical development & manufacturing operations

• Ability to effectively interact with and influence suppliers/vendors,  regulators, global partners or affiliates, industry executives, trade organizations

• Strong analytical problem-solving experience is essential; demonstrated prior experience in leading and motivating teams to conceptualize and develop innovative and creative solutions that are robust and sustainable

• Ability to prioritization and managing multiple complex situations, where precedent may not have been established.  Ambiguity and uncertainty will often be associated within the framework of decision making facing this individual

• Must possess exceptional communication, stakeholder management, team leadership, and interpersonal skills

• Must have excellent organizational and project management skills to coordinate multiple projects

• Proven leadership ability in managing and leading multidisciplinary teams

• Proven experience in devising and leading change, results orientation, action bias

• High degree of detail orientation and work accuracy are required

• Advanced English language skills

• Good IT-knowledge (e.g. SAP, MS-Office) as well as statistical analysis tools

• Willingness to domestic and international travel (role requires frequent travels to the sites)

Mindesteingruppierung/Minimum Grading: