Associate Director, GLP Quality Assurance

<body topmargin=0 leftmargin=0 marginheight=0 marginwidth=0> <table cellpadding=0 cellspacing=0 border=0><tr> <td valign="top" colspan=2 height=82 BGCOLOR="#9900CC" TEXT="#080000"> <div> <FONT SIZE="6" COLOR="#FFFFCC" FACE="Book Antiqua" ><B>The Artac Seel Company, Inc.</B></FONT><FONT SIZE="3" COLOR="#FFFF99" FACE="Book Antiqua" ><B> </B></FONT><FONT SIZE="3" COLOR="#FFFF80" FACE="Book Antiqua" ><B> </B></FONT><B>   </B><A HREF="index.htm" TARGET="_top" TITLE="TASC Home Page"><U><B>Home Page</B></U></A><B> </B></div> <div> <A HREF="id45.htm" TARGET="_top" TITLE="FULLTIME POSITIONS"><U>FULL-TIME POSITIONS</U></A>   |   <A HREF="id56.htm" TARGET="_top" TITLE="CONTRACT POSITIONS"><U>CONTRACT POSITIONS</U></A>   |   <A HREF="id48.htm" TARGET="_top" TITLE="RECRUITING"><U>RECRUITING</U></A>   |   <A HREF="id46.htm" TARGET="_top" TITLE="CONSULTING"><U>CONSULTING</U></A>   |   <A HREF="id49.htm" TARGET="_top" TITLE="ABOUT US"><U>ABOUT US</U></A></div> <div> </div> </td> </tr><tr> <td valign="top" width=340 BGCOLOR="#999980" TEXT="#080000"> <div> <B>Ellen Capito-Wightman, President</B></div> <div> <B>Corp. Phone  (860) 535-4419</B></div> <div> <B>FAX (860) 535-1842</B></div> <div> <A HREF="mailto: ellen@artacseel.com" TARGET="_top" TITLE="mailto: ellen@artacseel.com"><U><B>E-Mail to Ellen</B></U></A></div> <bR> <div> <B><U>FULL-TIME POSITIONS</U></B></div> <bR> <div> <A HREF="id108.htm" TARGET="_top" TITLE="Director, Compliance Regulatory Affairs"><U>Director, Compliance & Regulatory Affairs</U></A></div> <div> <A HREF="id107.htm" TARGET="_top" TITLE="Scientist II, DMPK "><U>Scientist II, DMPK </U></A></div> <div> <A HREF="id106.htm" TARGET="_top" TITLE="Exec. Dir., Early Clinical Development "><U>Exec. Dir., Early Clinical Development - Inflam. & Immunology</U></A></div> <div> <A HREF="id105.htm" TARGET="_top" TITLE="Global Medical Affairs Disease Leader (E"><U>Global Medical Affairs Disease Leader (Exec. Dir)</U></A></div> <div> <A HREF="id103.htm" TARGET="_top" TITLE="Exec. Dir., Clinical Research Physician,"><U>Exec. 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This position also includes responsibility for GLP compliance oversight of contract laboratories for nonclinical laboratory studies as well as for the assessment of GLP compliance training needs across the corporation followed by delivery of robust GLP compliance training. In addition he/she will identify opportunities for quality and process improvements in nonclinical development. </div> <bR> <div> <B><U>Responsibilities will include, but are not limited to, the following:</U></B></div> <div> Assess GLP compliance for global nonclinical development within each function conducting or supporting nonclinical laboratory studies.</div> <div> Maintain lead responsibility for the Quality Assurance Unit (QAU) to assure that Nonclinical laboratory studies are monitored throughout their conduct and reporting for compliance with GLP regulations.</div> <div> Maintain a copy of the master schedule of all nonclinical laboratory studies indexed by test article, test system, nature of study, date study was initiated, current status of each study and name of study director.</div> <div> Maintain copies of protocols and protocol amendments for all nonclinical laboratory studies.</div> <div> Assure the QAU performs the following:</div> <div> Inspects each nonclinical laboratory study at intervals adequate to assure the integrity of the study and that any problems determined through inspections which could affect study integrity are brought to the immediate attention of the study director and management. </div> <div> Periodically submits to management and the study director written status reports on each study, noting any problems and corrective actions taken.</div> <div> Determines that no deviations from approved protocols or standard operating procedures were made without  proper authorization and documentation</div> <div> Reviews the final study report to assure the report accurately describes the methods and standard operating procedures, and that the reported results reflect the raw data of the nonclinical laboratory study.</div> <div> Prepares and signs a statement to be included with the final study report which shall specify the dates inspections were made and findings reported to management and to the study director.</div> <div> Maintains records for  all activities conducted  to meet its responsibilities as described in written procedures</div> <bR> <bR> <bR> <div> <B>Responsibilities- cont'd                                                                                                                      Page 2</B></div> <bR> <div>  </div> <div> Implement and monitor global QA oversight of contract laboratories conducting or supporting nonclinical</div> <div>        laboratory studies sponsored by the company. </div> <div> Assure contract laboratories conducting or supporting nonclinical development sponsored by Celgene are qualified from the GLP compliance perspective prior to use.</div> <div> Ensure test and control article characterization and handling comply with GLP requirements.</div> <div> Assess GLP awareness and GLP compliance training needs for all employees managing and/or conducting nonclinical laboratory studies or supporting nonclinical development.</div> <div> Develop and provide GLP awareness and GLP compliance training across the company for those employees involved in conducting or supporting nonclinical development including formal effectiveness assessment and GLP training certification for each employee.  </div> <div> Partner, interact closely and establish strong liaison with global business partners in Research & Development, i.e. Early  Drug Development, <FONT SIZE="3" COLOR="#000000" FACE="Times New Roman" >Analytical Development, Information Technology, Quality & Compliance, Non-clinical Supplies and Regulatory Affairs </FONT>to ensure consistent global GLP compliance understanding.</div> <div> Identify opportunities for process improvement; plan, implement and evaluate changes in conjunction with corporate and department goals. </div> <div> Assist in the review and development of Nonclinical Development SOPs and Working Practices.</div> <div> Assist in preparation of budget and strategic plan for GLP compliance (QAU).</div> <div> Remain current in “state of the art” understanding of GLP compliance on a global basis including regional compliance enforcement experience with Health Authorities.</div> <bR> <div> <B>JOB REQUIREMENTS:</B> </div> <div> Proficient at Managing direct reports or others in a matrix environment</div> <div> Thorough knowledge of the nonclinical drug development process</div> <div> Expert understanding of FDA GLP regulations, OECD GLP Principles and local GLP requirements</div> <div> State of the Art awareness of compliance enforcement strategy undertaken by regional health authorities</div> <div> Excellent interpersonal, facilitation, presentation and communication skills with demonstrable tact and diplomacy</div> <div> Demonstrated ability to function in a team environment</div> <div> Experience developing, implementing and evaluating SOPs</div> <div> Ability to function in a highly matrixed organization</div> <div> Willingness to travel (up to 30%)</div> <bR> </tD> </tR> </TABLE></div> <div> <B><U>The Artac Seel Company</U></B></div> <div> --Effectively Delivering Talent in Pharmaceuticals & Biotech--</div> </td> </tr></table></body>