Associate Director Quality Operations Global API

<p><b>Working with Us</b><br/>Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.</p><p></p><p>Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: <a href="https://careers.bms.com/working-with-us" rel="noopener noreferrer" target="_blank"><span><span><span><span><span><span><span>careers.bms.com/working-with-us</span></span></span></span></span></span></span></a>.</p><p></p><p></p><p></p><p><b>Bristol Myers Squibb Ireland</b></p><p></p><p>Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units.</p><p></p><p>Ireland is home to External manufacturing’s global headquarters, the business unit responsible for the management of manufacturing contract operations (CMO’s) and ensuring reliable supply of product to patients across the Bristol Myers Squibb global network.</p><p></p><p>This includes management of, and working in conjunction with, third party contract manufacturers and internal manufacturing sites. In Ireland, External Manufacturing has two sites; Global Headquarters based in Dublin 15 and a distribution centre in Shannon, Co Clare.</p><p></p><p>For more information about Bristol Myers Squibb, visit us at BMS.com/ie</p><p></p><p></p><p><b>The Role</b></p><p></p><p>BMS External Manufacturing is looking to recruit a permanent<b><span> </span></b> <b><span>Associate Director Quality Operations Global API.</span></b></p><p></p><p><b>Key Duties and Responsibilities:</b></p><p></p><p>To lead the quality and compliance oversight management of third<br/>party manufacturers engaged by External Manufacturing within a<br/>cross functional team.<br/>• To ensure that the Quality resources working on priority Virtual Plant<br/>Teams (VPTs), or multiple VPTs are appropriate, effective and<br/>coordinated.<br/>• For specified products, lead a team to support the release activities in<br/>accordance with the conditions of our manufacturing authorization<br/>and provide strategic oversight on the API release process.<br/>• Proactively manage contract manufacturer relationships from a<br/>quality and compliance perspective.<br/>• Develop and manage the quality events, change control and market<br/>complaints programs in respect of Third Party Manufacturer and<br/>Alliance Partnership relationships.<br/>• Review process validation protocols and reports and also process<br/><span>verification/campaign</span> reported for CMO’s where relevant.<br/>• Review and approval of process risk assessment, process verification<br/>reports for CMO’s for intermediates and API. Support pre-approval<br/>inspections<br/>• Manage all activities associated with vendor approvals.<br/>• Actively support the BMS Fact Finding Investigations (FIT) and<br/>Product Review Committee (PRC) processes for major investigations<br/>involving Third Party products. Prepare and present the information<br/>to senior management in support of the FIT/PRC processes.<br/>• Provide quality/compliance subject matter expertise to the wider<br/>Supplier Relationship Management, Global Procurement, Supply<br/>Chain, QP and MT teams in support of new projects, technical<br/>transfers programs, supplier selection programs, investigations,<br/>validation programs, market release etc.<br/>• Provide the requisite quality support to Global BMS functional groups<br/>such as Global Regulatory/CMC and the local country based<br/>regulatory managers in support of regulatory filings, product renewals,<br/>regulatory agency questions etc.<br/>• Manage the quality metrics programs in relation to CMO performance.<br/>• Serve as the Quality Operations leader in Technical Transfer projects and Manufacturing Launch Teams (MLTs) relating to Third Parties.<br/>• Prepare, negotiate and approve Quality Agreements and purchase<br/>specs with CMO’s<br/>• Review and approve the Annual Product Reviews submitted by the<br/>CMO’s Support the Global BMS external auditing program by<br/>participation in audits of Third Parties as requested.<br/>• Manage information/provide information for quality council meeting.<br/>• Assess and implement corporate policies and directives<br/>• Select and retain Quality employees on VPTs<br/>• Allocate resources su