Senior Director Quality Assurance

<p>     </p><h2><b>JOB DESCRIPTION:</b></h2><p><span>Abbott Established Pharma Division (EPD) is looking for a</span></p><p></p><h1><b><span>Senior Director Quality Assurance</span></b><b> (m/f/d)</b></h1><p></p><p><span>to be based in Neustadt, Germany. </span></p><p></p><p></p><h2><b>Primary Job Function:</b></h2><ul><li><p>Responsible for developing and implementing  Quality strategy and execution for the Neustadt manfuacturing site and Hannover Development Centre QA Operations.</p></li></ul><p></p><p></p><h2><b>Core Job Responsibilities:</b></h2><p></p><p><b>Quality and Compliance</b></p><ul><li><p>Responsible &amp; accountable for Quality &amp; compliance in Neustadt manufacturing site and Hannover Development centre</p></li><li><p>Represent EPD as the key compliance/quality leader and decision maker responsible for appropriate quality outcomes for the business</p></li><li><p>Implement the organizational compliance/quality standards and lead the quality vision for the business</p></li><li><p>Implement a quality system based on sound science and application of the appropriate <span>quality/regulatory/legal</span> requirements</p></li><li><p>Drives the appropriate compliance/quality direction based on risk management principles, sound science and legal/regulatory requirements</p></li><li><p>Personify quality and compliance to EPD Germany external stakeholders, including regulatory agencies &amp; Key customers</p></li><li><p>Demonstrate continuous improvement in the quality performance of the products and the quality system through ongoing evaluation</p></li><li><p>Establish long and short term strategies that ensure an effective and compliant quality vision is implemented</p></li><li><p>Interpret the regulations and apply the appropriate standards to the quality planning process</p></li><li><p>Integrate expectations for continuous improvement in quality performance into the quality/business plan</p></li><li><p>Ensure the organization understands the quality strategy and how it impacts the quality system</p></li><li><p>Allocate resources based on quality system priorities and corresponding business needs</p></li></ul><p></p><p><b>Leadership and Problem Solving</b></p><ul><li><p>Execute the EPD Germany strategy in cooperation with other functions while balancing cultural, financial and resource constraints</p></li><li><p>Set goals for the business that are agreed upon and supported by all functional areas to advance the business</p></li><li><p>Maintain high expectations of the organization and its people for the effective implementation of the quality strategy</p></li><li><p>Right-size infrastructure to support business growth by improving the integration of new business and divestiture of existing products and businesses</p></li><li><p>Create a culture of innovation and set an appropriate pace of change in response to evolving business needs and global regulatory environment</p></li><li><p>Apply a global perspective; act with global and local understanding of different cultures/businesses and potential impacts on our products and markets</p></li><li><p>Leverage strength of quality system as a competitive advantage that drives profitability and customer satisfaction</p></li><li><p>Establish a learning culture that fosters knowledge transfer and best practice sharing, recognize and value these behaviors</p></li><li><p>Maintain a focus on customer engagement; proactively identify needs, solicit feedback, and address concerns in a timely manner</p></li><li><p>Represent Abbott strategically in the industry through professional <span>associations/advocacy</span></p></li></ul><p></p><p>Specifically for Hannover site</p><ul><li><p>Provide QA strategy leadership at the site</p></li><li><p>Lead Quality site activities </p></li></ul><ul><li><p>Manage assigned resources</p></li><li><p>ensure all site products compliance</p></li><li><p>Assist in resolving problems</p></li><li><p>Process queries from the authorities</p></li><li><p>Perform Quality Management at the site</p></li><li><p>Promote Innovation and continuous improvement</p></li></ul><p></p><p>Specifically for Neustadt site</p><ul><li><p>Technical and personnel management of the Quality areas within Neustadt site and overall oversight of</p></li><li><p>all Quality projects</p></li><li><p>Ensure the standard quality of the products manufactured at the site in line with applicable</p></li><li><p> quality guidelines &amp; quality systems</p></li><li><p>Assist in resolving difficulties or decision making in the subordinate areas</p></li><li><p>Support the team in quality audits by external inspectors, internal audits and processing inquiries from</p></li><li><p>the authorities, particularly on inspections</p></li></ul><p></p><h2><b><span>Supervisory/Management</span> Responsibilities:</b></h2><ul><li><p>Direct Reports: 8 - 10  </p></li></ul><p></p><p><b>Position <span>Accountability/Scope:</span></b></p><ul><li><p>Accountable for Quality leadership of EPD Neustadt