**Working with Us** 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. 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: careers.bms.com/working-with-us . **Bristol Myers Squibb Ireland** Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units. 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. 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. For more information about Bristol Myers Squibb, visit us at BMS.com/ie **Position Summary** Bristol-Myers Squibb is looking to recruit a Manager, Quality Assurance to provide quality and compliance oversight support to Pharma QP Operations This a 12 month fixed term contract position. **Key Responsibilities** • Directly support Qualified Persons within the QP team carrying out final release to market. • Compile batch release documentation into QP pack for review by the QP. • Complete QA Manager batch review checklists. • Identify and resolve batch release documentation issues. • Manage change controls, deviations and corrective actions associated with QP group activities. • Generation and maintenance of Batch Certificate templates. • Support cross-functional projects and continuous improvement initiatives. • Generate and coordinate metrics programs in relation to QP group activities. • Support QP activities relating to new product introduction, product launch preparation and technology transfer. • Provide support as needed to the BMS Fact Finding (FF) and Product Review Committee (PRC) processes for major investigations involving Third Party products. • Provide quality/compliance support as needed to the wider cross-functional Virtual Plant Teams. • Provide quality support as needed to Global BMS functional groups such as Global Regulatory/CMC and the local country based regulatory managers in support of regulatory filings, product renewals, regulatory agency questions etc. • Assist in the review of Quality Agreements with the Third Party Manufacturers and Alliance Partners. • Support the Global BMS internal self-inspection program. **Qualifications & Experience** + Minimum 2 years experience in a regulated environment, preferably the pharmaceutical industry in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency. + A BSc in a scientific discipline. + Knowledge of cGMP regulations pertinent to the USA, EU and other international markets. + Proven time management, organization and task prioritization skills. + Ability to develop cross-functional and external working relationships. + Strong communication and presentation skills. + QP Eligible (desirable) **Why you should apply** + You will help patients in their fight against serious diseases + You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees. + You'll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days of annual leave , access to BMS Cruiserath on-site gym and life assurance **\#LI-Hybrid** If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. **Uniquely Interesting Work, Life-changing Careers** With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. **On-site Protocol** BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. **Company:** Bristol-Myers Squibb **Req Number:** R1587125 **Updated:** 2024-11-13 03:12:21.723 UTC **Location:** Dublin-IE Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.