Manager, QA Compliance

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 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 and 2021. For more information about Bristol Myers Squibb, visit us at BMS.com/ie The Role BMS Cruiserath Biologics is seeking to recruit a permanent Manager, QA Compliance reporting to the QA Compliance Senior Manager. The Manager, QA Compliance will provide expert QA oversight for the lifecycle management of suppliers of materials and services used in Biologics Drug Substance manufacturing operations. In addition, the QA Compliance Manager will support multiple global programs, coordinating with stakeholders in the BMS network. Key Duties and Responsibilities: Coordinate lifecycle supplier management activities Conduct/lead supplier audits Support qualification of new suppliers/materials and requalification of existing. Assess supplier change notifications for impact to qualification status Support Material Certification program Review and Approve quality agreements Support local and global initiatives/projects relating to supplier management Coordinate local site direct dispense program Support the material release program on site to ensure raw materials and consumables are available for use in the MPCC Support the execution of the internal audit program Support global regulatory agency inspections and achievement of market approvals QA review, assessment and approval activities for GBL and MPCC, as applicable, for: Change controls Deviations/Investigations CAPAs Other associated documentation Co-ordination and support of the Deviations/ CAPA system including evaluation, resolution and close-out Authoring, review and approval of QA-related documentation including procedures and quality risk assessments (QRAs) Development and provision of training material and SOPs for QA function Qualifications, Knowledge and Skills Required: The successful candidate will hold a BSc in Science or related discipline, with a minimum 5-7 years’ QA experience in a bio-pharmaceutical environment (preferred). A clear understanding of cGMP requirements for supplier management, manufacturing and/or systems and compliance. The QA Manager will be required to work on his/her own initiative in addition to working as part of a team. The candidate must be able to work across a team matrix in order to meet accelerated timelines. Excellent communication & presentation skills are essential. The successful candidate must demonstrate excellent time management & organizational skills along with a proven ability to multi-task. 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 including an annual bonus, pension contribution, family medical allowance, 23.5 days annual leave plus 3 Company days, life assurance, on-site gym and gain-sharing bonus. BMSBL
LI-Hybrid 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.