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 Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company’s first European biologics manufacturing facility. This state of the art facility will produce multiple therapies for the company’s growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus. BMS Cruiserath has been awarded “Biopharma Company of the Year 2019” in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020, 2021 and 2022. The Role Reporting to the QA Technical Operations Senior Manager, the QA Technical Operations Manager will support the start-up of a commercial drug product manufacturing facility for its biologic’s commercial portfolio and clinical pipeline. During start-up this role will work in conjunction with the project team to provide resolution on questions as they arise during project design, construction, and qualification. They will support GMP design reviews, Contamination Control Strategy, Multiproduct Manufacturing Strategy during Basis of Design and Detailed Design phases of the project and support CQV through all phases of the project. In addition this role will have responsibility to provide direction on readying the facility for manufacturing operations, supporting the Tech Transfer program for new products introduced into the facility. Responsibilities will include the following: Investigation System Owner with responsibility for SDP, and Warehouse, Material, Engineering and EM issues as they relate to SDP: Manage the investigation triage business process Investigation SME during Health Authority inspections QA Technical Operations Representative at Investigations Review Board (IRB) and Site Quality Council Liaise with network Manufacturing sites/Suppliers for complex investigations. Quality Approver for local and complex multi-site investigations, deviations and subsequent CAPAs Site Representative at the Global Investigations Community of Practice meetings and Local Process Owner meetings as applicable Support Implementation of Site Initiatives to prevent deviation recurrence. Metrics champion to ensure targets are achieved and remediation plans are in place when applicable Manager designee for QA and cross-functional meetings QA Lead for complex change controls QA Lead for New Product Introduction and Tech Transfer Projects QA Lead for cross-functional projects at a site level and site representative on global projects Support the maintenance of Maximo, MES and SAP at BMS Cruiserath Biologics (including establishment/set up for SDP) Support the Site Validation and Qualification activities Preparation and QA review of Annual Product Quality Review reports (APQRs) as applicable Support the hiring, development and coaching of key members of the QA Technical Operations team. Drive implementation of efficiency improvements in the Quality Department on a continuous basis and participation in site continuous improvement initiatives Review and approval of GMP documentation, including plans, protocols, reports, SOPs, forms, directives, policies and validation documentation Qualifications and Experience required: A minimum of a Bachelors Degree in Science or a related technical discipline, with a minimum of 5 years’ Quality experience in the biopharmaceutical industry Demonstrated knowledge of applicable EU, FDA and other regulatory requirements. A strong technical aptitude, global regulatory experience and demonstrated experience interfacing with regulators A thorough understanding of cGMP requirements for areas of responsibility. Demonstrated in-depth knowledge of deviation and change management processes Competencies: Ability to work on own initiative in addition to working as part of a team Capable of positively influencing others to bring resolution to complex issues Ability to work across a team matrix in order to meet accelerated timelines Excellent communication skills are essential Excellent trouble shooting and problem-solving skills as well as an ability to coach and mentor individuals or teams through complex problems Demonstrated ability to recognise issues, highlight risks and prioritise workload based on site goals Excellent time management & organisational skills along with a proven ability to multi-task Ability to challenge the status quo with a growth mindset 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 an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym
LI- Onsite 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
[email protected]. Visit careers.bms.com/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. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.