Senior Manager CSCQ, Qualified Person

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. 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. The Role Bristol Myers Squibb is looking to recruit a permanent Senior Manager CSCQ, Qualified Person. This is a position within the Supply Chain In Market Quality (SCIMQ) organisation that is responsible for the oversight of CSC Quality activities including CSC Logistics EMEA/ASIA PAC operations. The position is responsible for EU Qualified Person (QP) certification and release activities for supply to clinical trials, audit of internal GMP systems/processes and suppliers/third party contractors, as well as assisting stakeholders with regulatory advice and preparation for and management of regulatory agency inspections. This position provides support for the identification and resolution of critical quality issues that may affect BMS. Key Duties and Responsibilities: Support start-up activities for Clinical Supply Chain Quality Dublin, including but not limited to: * Review and approval of QA/QP related procedures * Support preparation and approval of training materials * Support review and approval of Quality Agreements * Ensure knowledge transfer from current release site * Support Manufacturer(s)/Importation Authorisation submissions as required Support sustaining operations, including but not limited to: * Qualified Person release of IMP’s in accordance with BMS procedures and regulatory requirements * Provide support to Health Authority GMP/GDP inspections and audits across the supply chain * Advise stakeholders on quality issue management and process enhancement/compliance, ensuring consistent quality standards and fostering strong working relationships * Incorporate global regulatory trends and changes into Supply Chain Quality. * Support Site Master File maintenance * Oversee Manufacturer(s)/Importation Authorisation update and maintenance * Ensure rapid communication of quality issues, including potential misconduct or issues of significant deviations with project/products to business partners and senior management * Review and approve procedural documents * Participate in multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline * Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level * May influence the external environment through interactions with regulators, trade associations, or professional societies * Proactively identify risk areas * Provide input in the global audit plans based on identified signals/trends/risks/gaps * Supervise QA personnel as assigned. * Undergo continuous professional development including self-study, site visits, internal and external training courses and audits * Support OPEX programs and champion continuous quality improvement initiatives and other efficiency initiatives Qualifications, Knowledge and Skills Required: * University degree (Science degree preferred) * Eligibility to act as an EU Qualified Person i.e. either an EU Pharmacy degree or other equivalent qualification. * Experience as a...