Regional Compliance Manager

<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>JOB DESCRIPTION:</b></h2><p><b>About Abbott</b> </p><div><p>Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.  </p><p></p><p><b>Working at Abbott </b> </p><p>At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:  </p><ul><li><p>Career development with an international company where you can grow the career you dream of . </p></li><li><p>A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.  </p></li><li><p>A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.  </p></li></ul><p></p><p><b>What You’ll Do</b></p><p>Primary Job Function:</p></div><p>As an experienced resource, function is responsible for leading continuous improvement initiatives, compliance initiatives, and risk assessments involving various areas under scope of responsibility, including but not limited to LATAM Abbott manufacturing sites.</p><p></p><p>Core Job Responsibilities:</p><p>Manages assigned regional quality projects, and compliance driven initiatives and provides support for the implementation of compliance related initiatives within the EPD LATAM manufacturing sites.</p><p>Acts as regional subject matter expert (SME) in Quality Systems and Compliance topics. Provide support for external regulatory audits / preapproval inspections / Corporate and Divisional audits within the region. Identify critical points for improvements and assure reduce risks in future audits.</p><p>Works with the Division to support and implement compliance related initiatives in the Region.</p><p>Provides inspection readiness support to EPD locations, as applicable, through the identification of compliance gaps and risks, and participation in the remediation process.</p><p>Monitors and supports internal audit programs in LATAM sites.</p><p>As part of the audit support, assess the appropriateness and timeliness of proposed CAPAs, and track CAPА</p><p>follow up to closure. Act as the regional independent reviewer for CAPAs and investigations.</p><p>Checks effectiveness of the CAPA process.</p><p>Maintains an excellent understanding of actual and future regulatory expectations and provide support for compliance inside the region and sites.</p><p>Support sites with problem resolution and mitigation of quality related issues with onsite visits as defined by criticality of the issue and overall impact to product and deliverables.</p><p>Identifies potential problem areas and works with cross functional teams to implement corrective actions and mitigation actions as needed.</p><p>Ensure Abbott policies, procedures, and regulatory agency requirements are met and effectively maintained.</p><p>Reports on weaknesses, ineffective procedures, policy exceptions and discrepancies and recommends appropriate corrective actions.</p><p></p><p><b>Required Qualifications</b></p><ul><li><p>Minimum Education: College or University Bachelor&#39;s degree in Science related field such as Pharmacists, Chemist, Engineer,</p></li><li><p>Biology.</p></li><li><p>Minimum Experience/Training Required: Quality Related experience in Pharmaceutical business (&#43;5 years).</p></li><li><p>Strong leadership and communication skills.</p></li><li><p>Experience working with manufacturing sites required.</p></li><li><p>Technical expertise and knowledge gained through experience are crucial elements for success in chemical and pharmaceutical processes.</p></li><li><p>Experience in Validation and Risk Management concepts.</p></li><li><p>Experience in conducting and handling audits and inspections.</p></li><li><p>Strong knowledge of relevant regulations for quality systems and compliance.Ability to effectively interact with, manage, motivate and influence internal and external business partners.</p></li><li><p>Experience in Microsoft tools (Excel, Power Point, Word, etc.)</p></li><li><p>Requires international travel based on business needs.</p></li><li><p>Fluent in English.</p></li></ul><p></p><p>Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. </p><p>Connect with us at <a href="http://www.abbott.com/" target="_blank"><u>www.abbott.com</u></a>, on Facebook at <a href="http://www.facebook.com/Abbott" target="_blank"><u>www.facebook.com/Abbott</u></a> and on Twitter &#64;AbbottNews and &#64;AbbottGlobal. </p><p></p><p></p><p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><p><b>The base pay for this position is </b></p>N/A<p style="text-align:left"><span>In specific locations, the pay range may vary from the range posted.</span></p><p style="text-align:inherit">     </p><h2><b>JOB FAMILY:</b></h2>Support Services<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>DIVISION:</b></h2>EPD Established Pharma<p style="text-align:inherit">&nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</p><h2><b>LOCATION:</b></h2>Peru &gt; Lima : Jr. Carlos Alayza y Roel<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>ADDITIONAL LOCATIONS:</b></h2><p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>WORK SHIFT:</b></h2>Standard<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>TRAVEL:</b></h2>Not specified<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>MEDICAL SURVEILLANCE:</b></h2>Not Applicable<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>SIGNIFICANT WORK ACTIVITIES:</b></h2>Not Applicable<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><p style="text-align:inherit">     </p><p style="text-align:inherit">     </p>