About this role
<p> <style type="text/css">table.MiTabla { max-width: 1020px;!important </style> </p> <table border="0" cellpadding="0" cellspacing="0"> <tbody> <tr> <td><img align="top/" alt="" src="https://staticweb.grifols.com/documents/675849/2554718/SSFF_04_SC.jpg/49578aa8-332f-ed12-fb9a-5335a6228990?t=1636640426088"></td> </tr> <tr> <td> <p style="text-align:justify">Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.</p> </td> </tr> <tr> <td><img src="https://staticweb.grifols.com/documents/675849/2554709/SuccesFactors_1020x93_jobposting_line_test.png/e2cffc87-a707-9e08-b5ef-081cae1f1ecf?t=1636640341637" width="100%"></td> </tr> </tbody> </table> <p style="margin:0.0cm;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif;text-align:center"><span style="font-size:14.0pt"><strong><span style="font-family:Verdana, sans-serif;color:#404040">Quality Manager</span></strong></span></p> <p style="margin:0.0cm;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040"> </span></strong></p> <p style="margin:0.0cm;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040"> </span></strong></p> <p style="margin:0.0cm 0.0cm 6.0pt;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><u><span style="font-family:Verdana, sans-serif;color:#404040">Role:</span></u></strong></p> <p style="margin:3.0pt 0.0cm 0.0cm;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:black">Responsible person according international and local laws for maintaining a Quality System based on applicable Good Distribution Practices principles and Corporate Quality standards of medicinal products and medical devices.</span></p> <p style="margin:0.0cm;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0cm 0.0cm 6.0pt;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><u><span style="font-family:Verdana, sans-serif;color:#404040">Activities and responsibilities:</span></u></strong></p> <ol style="margin-top:3.0pt;margin-bottom:0.0cm"> <li style="margin:3.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:13.7953px"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">Be the Responsible Person as per GDP requirements.</span></li> <li style="margin:3.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:13.7953px"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">To assure distribution activities (procurement, storage, complaints management…), to be in compliance with Good Distribution Practices regulation. </span></li> <li style="margin:3.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:13.7953px"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">Elaborate, approve and keep updated relevant SOPs and records.</span></li> <li style="margin:3.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:13.7953px"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">Responsible for the local batch release of medicinal products and medical devices in compliance with and local requirements.</span></li> <li style="margin:3.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:13.7953px"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">Responsible to approve returns to saleable stock.</span></li> <li style="margin:3.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:13.7953px"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">Overview of GDP subcontracted activities and service providers (initial and regular requalification, audits, CAPA follow up, quality agreements, performance, etc…)</span></li> <li style="margin:3.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:13.7953px"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">Review of publicity messages and promotional material from a Regulatory perspective. </span></li> <li style="margin:3.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:13.7953px"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">Responsible and local contact for pharmacovigilance.</span></li> <li style="margin:3.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:13.7953px"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">To obtain and keep updated all the licenses necessary for products and/ordistribution activities.</span></li> <li style="margin:3.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:13.7953px"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">Regulatory Affairs local contact person with local authorities and Headquarters.</span></li> <li style="margin:3.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:13.7953px"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">Implementation, maintenance and continuous improvement of a quality system according to GDP regulations and Corporate Quality standards: record and coordination of complaints, deviations, CAPAs, change control, risk analysis, internal and external audits.</span></li> <li style="margin:3.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:13.7953px"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">Host Authorities Health inspections and internal, corporate or customer audits</span></li> <li style="margin:3.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:13.7953px"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">Liaison with National Regulatory Authority of the country and neighboring countries.</span></li> <li style="margin:3.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:13.7953px"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">Liaising with other parties including with Quality personnel at manufacturing sites, Logistics and Customer Services, headquarters, etc.</span></li> <li style="margin:3.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:13.7953px"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">Ensure training programmes are implemented, maintained, and effective for all relevant staff.</span></li> <li style="margin:3.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:13.7953px"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">Lead and coordinate recall operations</span></li> <li style="margin:3.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:13.7953px"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">Other applicable by local laws.</span></li> </ol> <p style="margin:0.0cm;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0cm;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0cm 0.0cm 6.0pt;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><u><span style="font-family:Verdana, sans-serif;color:#404040">Academic requirements:</span></u></strong></p> <p style="margin:0.0cm;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">Degree in Pharmacy.</span></p> <p style="margin:0.0cm;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040"> </span></strong></p> <p style="margin:12.0pt 0.0cm 6.0pt;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><u><span style="font-family:Verdana, sans-serif;color:#404040">Knowledge skills and abilities:</span></u></strong></p> <ul style="margin-top:6.0pt;margin-bottom:0.0cm"> <li style="margin:6.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">Strong resourcefulness and ability to proactively seek information, engage with stakeholders and independently resolve issues.</span></li> <li style="margin:6.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">Excellent organizational skills.</span></li> <li style="margin:6.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">Excellent attention to detail.</span></li> <li style="margin:6.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">Team Player and strong interpersonal skills.</span></li> </ul> <p style="margin:6.0pt 0.0cm 0.0cm 35.7pt;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0cm 0.0cm 6.0pt;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><u><span style="font-family:Verdana, sans-serif;color:#404040">Professional Experience:</span></u></strong></p> <ul style="margin-top:6.0pt;margin-bottom:0.0cm"> <li style="margin:6.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:black">5 years’ experience managing a Quality System in a similar position, </span></li> <li style="margin:6.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:black">Experience in GDP.</span></li> <li style="margin:6.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:black">In-depth knowledge of Polish and EU legislation applicable to medicinal products and medical devices.</span></li> <li style="margin:6.0pt 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:black">Regulatory Affairs experience preferred.</span></li> </ul> <p style="margin:0.0cm;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0cm;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><u><span style="font-family:Verdana, sans-serif;color:#404040">Scope</span></u></strong><strong><u><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">:</span></u></strong></p> <p style="margin:0.0cm;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040"> </span></strong></p> <p style="margin:0.0cm;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">Countries associated to the affiliate (Poland and other </span><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">Baltic countries).</span></p> <p style="margin:0.0cm;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040"> </span></strong></p> <p style="margin:0.0cm 0.0cm 6.0pt;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0cm 0.0cm 6.0pt;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><u><span style="font-family:Verdana, sans-serif;color:#404040">IT</span></u></strong><strong><span style="font-family:Verdana, sans-serif;color:#404040">:</span></strong></p> <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">Proficient in Microsoft Office (especially Excel and Word).</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">SAP user level.</span></li> </ul> <p style="margin:0.0cm;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Verdana, sans-serif;color:#404040"> </span></strong></p> <p style="margin:0.0cm;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Verdana, sans-serif;color:#404040"> </span></strong></p> <p style="margin:0.0cm 0.0cm 6.0pt;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><u><span style="font-family:Verdana, sans-serif;color:#404040">Languages:</span></u></strong></p> <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">Local language </span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:10.0pt;font-family:Verdana, sans-serif;color:#404040">ENGLISH: advanced level.</span></li> </ul> <p style="margin:0.0cm 0.0cm 0.0cm 18.0pt;text-align:justify;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p><span style="font-size:8.0pt">#LI-HJ1</span></p> <p><span style="font-size:8.0pt">#LI-Hybrid</span></p><p><img src="https://staticweb.grifols.com/documents/675849/2554709/SuccesFactors_1020x93_jobposting_line_test.png/e2cffc87-a707-9e08-b5ef-081cae1f1ecf?t=1636640341637" width="100%"></p> <p><b>Location: <span>EMEA : Poland : Warsaw</span>:<span>Polska</span></b> </p> <p> </p> <p><a href="http://www.grifols.com/es/web/international/home" target="_blank">Learn more about Grifols</a></p> <p> </p>