Senior Manager API Quality Operations

<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><b>The Role</b></p><p></p><p>BMS External Manufacturing is looking to recruit a fixed-term <b><span> Senior Manager API Quality Operations </span></b><span>to</span><b><span> </span></b> p<span>rovide quality operations and compliance oversight management to Active Pharmaceutical Ingredient and intermediate contract manufacturing organisations (CMO) engaged by External Manufacturing within a cross functional team</span></p><p></p><p></p><p><b>Key Responsibilities:</b></p><p></p><ul><li><p>Proactively manage contract manufacturer relationships from a quality and compliance perspective. Build strong effective working relationships with CMO’s </p></li><li><p>Quality lead for a Virtual Plant Team (VPT) or managing a significant portfolio at a CMO </p></li><li><p>Develop and manage the quality events, change control and market complaints programs in respect of contract manufacturers. Ensure an effective deviation management system is in place to deal with vendor non-conformances from third party suppliers. Review process validation protocols and reports and also process <span>verification/campaign</span> reports for CMO’s where relevant. </p></li><li><p>Ensure Quality by Design (QbD) principles are implemented for all new products at CMO’s. Review and approval of process risk assessment, process verification reports for CMO’s for intermediates and Active Pharmaceutical Ingredient (API). Support pre-approval inspections </p></li><li><p>Manage all activities associated with vendor approvals </p></li><li><p>Provide quality/compliance subject matter expertise to the wider Supplier Relationship Management, Global Procurement, Supply Chain and Manufacturing Science &amp; Technology (MS&amp;T) teams in support of new projects, technical transfers programs, supplier selection programs, investigations, validation programs, etc. </p></li><li><p>Provide the requisite quality support to Global Bristol Myers Squibb (BMS) functional groups such as Global Regulatory/Chemistry Manufacturing and Controls (CMC) and the local country based regulatory managers in support of regulatory filings, product renewals, regulatory agency questions, etc. </p></li><li><p>Manage the quality metrics programs in relation to CMO performance</p></li><li><p>Serve as the Quality Operations Leader in Technical Transfer projects and Manufacturing Launch Teams (MLTs) relating to Third Parties </p></li><li><p>Prepare, negotiate and approve Quality Agreements and purchase specs with CMO’s</p></li><li><p>Review and approve the Annual Product Reviews submitted by the CMO’s Support the Global BMS external auditing program by participation in audits of Third Parties as requested</p></li><li><p>Mange information/provide information for quality council meeting  </p></li><li><p>Assess and implement corporate policies and directives </p></li><li><p>Liaise with auditors of external vendors and suppliers. Review vendor audits to identify trends. Manage audit observation closure.</p></li><l