Quality Systems Senior Specialist

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Bristol Myers Squibb Ireland Bristol Myers Squibb is a leading global biopharma company focused on discovering, developing and delivering innovative medicines for patients with serious diseases in areas including oncology, haematology, immunology, cardiovascular and neuroscience. Our employees work every day to transform patients’ lives through science. Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units. Many of the global business services, including the European Treasury Centre, Market Supply Operations and Commercial Operations have a presence in Ireland. Ireland is also 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. 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. For more information about Bristol Myers Squibb, visit us at BMS.com/ie The Role BMS External Manufacturing is looking to recruit a permanent Senior Specialist, Quality Systems. The Quality Systems Senior Specialist is responsible for implementing, supporting and monitoring of the effectiveness of the Quality Systems within the Global External Manufacturing organization. Key Duties and Responsibilities: The Quality System Senior Specialist will carry out duties relevant to Quality Systems processes within Global External Manufacturing. Carry out Quality Systems duties relevant to the process including relevant procedures/ forms, training materials, share point content, metrics where applicable Display technical knowledge of the process and understand risks/weaknesses in the system Responsible for ensuring the elements of the process are compliant with Regulatory requirements, Health Authority expectations and with BMS policies/ directives where applicable. Responsible for ensuring the elements of the process are current and reflect current practices Support subject matter expert for review of regulatory or directive changes. Regularly review the process (trends metrics, trends observations, RFT, Design, waste elimination) for their effectiveness and provide feedback to the Quality management team for action and remediation Carry out activities to implement Health Authority commitments related to the process Support the subject matter expert in audits / inspections Participate in pro-active continuous improvement plans for the process for example Value Stream Mapping and identification of weak elements, regulatory surveillance Quality Systems include Product Quality Complaints, Deviation Investigations, CAPA, complaints, change control, Quality Risk Management, Documentation, Training, Audits and Inspections and Supplier Management. There will be 5% travel associated with this role. Other Ad hoc duties will be required which will include but not be limited to the following: Author, review and approve QMS documents Process QMS documents in the electronic document management system Participate in and support Permanent Inspection Readiness activities Maintain the Quality Risk Register for ExM Monitor the periodic review of Quality Systems documents Maintain the system and process for record management Maintain the system for update of ExM GxP Authorizations Act as facilitator and reviewer of Quality System Framework updates Act as ExM Quality System representative on ExM and Global Quality projects Support the scheduling, execution, reporting, follow up and tracking of self-inspections audits. Support preparation of and participate in Quality Council meetings Perform self-inspection audits as part of the audit team. Review regulatory inspection observations from other BMS sites for site compliance. Identify and implement continuous improvement opportunities for Quality System owned processes Act as qualified trainer for Quality Systems owned processes. Qualifications, Knowledge and Skills Required: Essential Works under minimum supervision and exhibits a positive work attitude and high productivity Detail-oriented, well organised and have excellent verbal and written communication skills as well as excellent organization and follow-up skills Candidate must be flexible and comfortable working in a fast-paced environment with aggressive and dynamic timelines. Excellent interpersonal skills Ability to collaborate, facilitate, and support standard practices across multiple functional groups in diverse geographical locations are required; self-motivated Strong presentation skills; confident public speaker Ability to multi-task numerous projects Ability to achieve targets and milestones Can prioritize workload based on changing business needs Ability to recognize topics / decisions requiring escalation Ability to work with initiative and manage own work load Proficient in the use of Microsoft Office programs including OneNote and SharePoint platforms Fluent English is required. Desirable Experience in a GxP Manufacturing site Technical writing training / qualification Lead investigator training Qualified auditor Lean Six Sigma qualification Project Management qualification Supervision of work of direct or indirect reports Required A science related degree in Chemistry, Engineering or Biotechnology Experience in a pharmaceutical Quality related role, preferably within a Quality Systems team A strong working knowledge of GxP regulations in the European Union (EU), United States (US) and other relevant global markets Knowledge of OPEX tools Experience in leading or participation in project teams What’s important to us Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases: Passion: Our dedication to learning and excellence helps us to deliver exceptional results. Innovation: We pursue disruptive and bold solutions for patients. Urgency: We move together with speed and quality because patients are waiting. Accountability: We all own BMS’ success and strive to be transparent and deliver on our commitments. Integrity: We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues. Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential. We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve. 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 Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. 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.