Vice President (VP) – Quality Management (Sterile Manufacturing, Pharmaceuticals) & Internal Audits (m/f/d)

<h2>Your assignments</h2><p></p><p><b><span>Strategic Quality Leadership</span></b></p><ul><li><p>Develop and implement <b>global quality strategies</b> aligned with company objectives.</p></li><li><p>Ensure compliance with <b>cGMP, FDA, EMA, and other international regulatory requirements</b>.</p></li><li><p>Establish strict quality standards for <b>sterile manufacturing</b> environments, including aseptic processing and contamination control.</p></li><li><p>Act as speaking partner for <b>regulatory agencies</b> for audits, inspections, and certifications.</p></li><li><p>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).</p></li></ul><p></p><p><b>Quality Management &amp; Compliance</b></p><ul><li><p>Oversee <b>risk management</b> strategies related to contamination prevention, validation, and environmental monitoring.</p></li><li><p>Ensure compliance with regulatory guidelines, including <b>FDA 21 CFR Part 211, CFR Part 4, ICH Q9, ICH Q10</b>, and pharmacopoeia standards (USP, EP, JP).</p></li><li><p>Support quality investigations for deviations, CAPAs, and field safety corrective actions, ensuring timely resolution.</p></li><li><p>Develop and manage <b>quality policies and SOPs</b>, ensuring alignment with best practices.</p></li></ul><p></p><p><b>Manufacturing &amp; Operational Excellence</b></p><ul><li><p>Partner with <b>manufacturing, engineering, and supply chain teams</b> to optimize sterile production efficiency.</p></li><li><p><span>Implement process validation and continuous improvement initiatives to enhance quality.</span></p></li><li><p><span>Support lean manufacturing and Six Sigma principles to optimize quality assurance mechanisms.</span></p></li><li><p><span>Establish robust training programs to educate staff on aseptic techniques and compliance standards.</span></p></li><li><p><span>Support of overarching QA &amp; QC efficiency programs to contribute to Fresenius Kabi’s target for affordable medicines and services.</span></p></li><li><p><span>Being responsible for the budget allocated to these functions.</span></p></li><li><p><span>Planning, performance and assessment of internal quality audits.</span></p></li></ul><p></p><p><b><span>People &amp; Leadership Development</span></b></p><ul><li><p><span>Lead and mentor a high-performing quality management and compliance team.</span></p></li><li><p><span>Foster a culture of continuous improvement, accountability, and excellence.</span></p></li><li><p><span>Guide executive leadership on quality trends, risks, and innovations within the industry.</span></p></li></ul><p></p><h2><span>Your profile</span></h2><ul><li><p><span>Advanced degree in Pharmacy, Microbiology, Chemistry, Engineering, or related field</span></p></li><li><p><span>15+ years of experience in quality management and/or operational functions within sterile pharmaceutical manufacturing, as well as significant manufacturing<span> </span>quality experience with progressive challenging QA/QC leadership in pharmaceutical or related industry</span></p></li><li><p><span>Excellent expertise in cGMP, FDA, EMA, ICH guidelines, and aseptic processing regulations</span></p></li><li><p><span>Excellent knowledge in pharmaceutical technology to produce sterile products (SVPs, LVPs) including aseptic manufacturing</span></p></li><li><p><span>Strong leadership, strategic thinking, and problem-solving abilities</span></p></li><li><p><span>Enhanced expertise in interpretation of GxP regulations</span></p></li><li><p><span>Active experience with US-FDA and EU-authority inspections</span></p></li><li><p><span>Understanding of key financial and operating indicators for pharmaceutical companies</span></p></li><li><p><span>Accomplished quality leader with relevant experience in injectable, aseptic pharmaceutical development &amp; manufacturing operations</span></p></li><li><p><span>Ability to effectively interact with and influence suppliers/vendors,<span>  </span>regulators, global partners or affiliates, industry executives, trade organizations</span></p></li><li><p><span>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</span></p></li><li><p><span>Ability to prioritization and managing multiple complex situations, where precedent may not have been established.<span>  </span>Ambiguity and uncertainty will often be associated within the framework of decision making facing this individual</span></p></li><li><p><span>Must possess exceptional communication, stakeholder management, team leadership, and interpersonal skills</span></p></li><li><p><span>Must have excellent organizational and project management skills to coordinate multiple projects</span></p></li><li><p><span>Proven l