Consultant for the QA Harmonization Project in European Affiliates (m/f/d)

Rahmendaten

<span style="font-size: 12.0pt;"><span style="font-family: Aptos , sans-serif;"><strong><span style="font-size: 18.0pt;">Consultant for the QA Harmonization Project in European Affiliates (m/f/d)</span></strong></span></span> <div> </div> <p><span style="font-size: 12.0pt;"><span style="font-family: Aptos , sans-serif;"><strong><span style="font-size: 13.5pt;">Project Overview:</span></strong></span></span><br> <span style="font-size: 12.0pt;"><span style="font-family: Aptos , sans-serif;">We are seeking an experienced <strong>Quality Assurance (QA) Consultant</strong> to support the QA Harmonization Project across European affiliates. The goal of the project is to align and standardize quality systems, processes, and procedures (SOPs) across multiple countries to ensure regulatory compliance and operational consistency.</span></span><br> <span style="font-size: 12.0pt;"><span style="font-family: Aptos , sans-serif;">This role requires strong expertise in <strong>GMP/GDP regulations</strong>, hands-on experience in <strong>Quality Assurance / Quality Management</strong> within the pharmaceutical industry, and excellent project management skills. The consultant will act as a project manager and quality advisor, ensuring successful collaboration between global teams and local affiliates.</span></span></p> <p> </p> <div style="margin-bottom: 8.0pt;margin-left: 0.0cm;margin-right: 0.0cm;margin-top: 0.0cm;text-align: center;"> <hr></div> <span style="font-size: 12.0pt;"><span style="font-family: Aptos , sans-serif;"><strong><span style="font-size: 18.0pt;">Project Details:</span></strong></span></span> <ul> <li style="margin: 0.0cm 0.0cm 8.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Aptos , sans-serif;"><strong>Start Date:</strong> 26. May 2025</span></span> <li style="margin: 0.0cm 0.0cm 8.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Aptos , sans-serif;"><strong>End Date:</strong>  January 2026</span></span> <li style="margin: 0.0cm 0.0cm 8.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Aptos , sans-serif;"><strong>Workload:</strong> 25 hours per week</span></span> <li style="margin: 0.0cm 0.0cm 8.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Aptos , sans-serif;"><strong>Location:</strong> Remote (90% remote work, no travel required)</span></span> </ul> <div style="margin-bottom: 8.0pt;margin-left: 0.0cm;margin-right: 0.0cm;margin-top: 0.0cm;text-align: center;"> <hr></div> <span style="font-size: 12.0pt;"><span style="font-family: Aptos , sans-serif;"><strong><span style="font-size: 18.0pt;">Key Responsibilities:</span></strong></span></span> <ul> <li style="margin: 0.0cm 0.0cm 8.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Aptos , sans-serif;">Act as <strong>project manager</strong> for the QA Harmonization Project, managing and consulting individual working groups.</span></span> <li style="margin: 0.0cm 0.0cm 8.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Aptos , sans-serif;">Provide <strong>quality assurance guidance</strong> and share best QA practices with the working teams and their leads.</span></span> <li style="margin: 0.0cm 0.0cm 8.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Aptos , sans-serif;">Organize <strong>team reviews and alignment meetings</strong> to ensure project transparency and team engagement.</span></span> <li style="margin: 0.0cm 0.0cm 8.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Aptos , sans-serif;">Monitor adherence to the <strong>project plan, milestones, and timelines</strong>.</span></span> <li style="margin: 0.0cm 0.0cm 8.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Aptos , sans-serif;">Consult relevant internal functions on QA-related topics.</span></span> <li style="margin: 0.0cm 0.0cm 8.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Aptos , sans-serif;">Support and consult the <strong>implementation of harmonized processes</strong> in the European affiliates.</span></span> <li style="margin: 0.0cm 0.0cm 8.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Aptos , sans-serif;">Organize and coordinate <strong>training sessions for core SOPs</strong> to ensure effective knowledge transfer.</span></span> </ul> <p style="margin-bottom: 8.0pt;margin-left: 0.0cm;margin-right: 0.0cm;margin-top: 0.0cm;"> </p> <div style="margin-bottom: 8.0pt;margin-left: 0.0cm;margin-right: 0.0cm;margin-top: 0.0cm;text-align: center;"> <hr></div> <span style="font-size: 12.0pt;"><span style="font-family: Aptos , sans-serif;"><strong><span style="font-size: 18.0pt;">Requirements:</span></strong></span></span> <ul> <li style="margin: 0.0cm 0.0cm 8.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Aptos , sans-serif;">Excellent knowledge of <strong>international GMP/GDP regulations</strong> and <strong>Quality Management Systems</strong>.</span></span> <li style="margin: 0.0cm 0.0cm 8.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Aptos , sans-serif;">A minimum of <strong>5 years of relevant experience</strong> in the pharmaceutical industry within <strong>Quality Assurance and/or Quality Management</strong>.</span></span> <li style="margin: 0.0cm 0.0cm 8.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Aptos , sans-serif;">Strong <strong>assertiveness and communication skills</strong>, combined with a <strong>diplomatic approach</strong> in negotiations and multicultural environments.</span></span> <li style="margin: 0.0cm 0.0cm 8.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Aptos , sans-serif;">Proven <strong>project management skills</strong>, including the ability to lead cross-functional and international teams.</span></span> <li style="margin: 0.0cm 0.0cm 8.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Aptos , sans-serif;">High attention to quality, structured working style, and a <strong>solution-oriented mindset</strong>.</span></span> <li style="margin: 0.0cm 0.0cm 8.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Aptos , sans-serif;"><strong>Very good written and verbal English skills</strong> (English is the project language).</span></span> </ul>