Supply Chain In-Market Associate Quality Manager

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. Supply Chain In-Market Associate Quality Manager Department: Global Supply Chain & In-Market Quality Objective of the job: Ensures the implementation and maintenance of quality management system, for the distribution activities with BMS product in the Market. Identifies, communicates and escalates quality issues and decisions, which impact the business. Supports compliance of market Third Party Distribution partners to BMS Quality requirements related to distribution and transportation. Embraces continuous improvement activities for more effective Quality systems across the organization. Key responsibilities and major duties: 1. Ensure that a Quality Management System is implemented and maintained in the local market, including: * Acts as the local back-up / designee to Quality Responsible Person in accordance with Market regulatory requirements * Supports and maintains Quality System Documentation: procedures and records o BMS Policy/Directives/SOPs impact assessment and implementation o GDP and Local regulations impact assessment and implementation * Ensures initial and continuous GMP/GDP training programs are implemented and maintained, including product identification and avoidance of falsified * Support and maintains locally the Quality Manual * Ensures that relevant customer complaints are dealt with effectively * Performs periodic Self-inspections according with the self-inspection plan and puts in place necessary corrective measures * Supports and ensures deviation investigations and CAPA management impacting the UK/IE markets * Supports the implementation of the Change Controls impacting UK/IE markets * Reviews the APQRs, as required per local regulations * Preparation and support of the Quality Management Review/Quality Council of the Market * Reports quality metrics and monthly market updates, prepares Deep Dive Analysis for missed metrics 2. Ensures implementation of following Quality Operations: * Suppliers management oversight: Quality Agreements, approving any local subcontracted activity which may impacts product quality, evaluate and confirm the overview of the supplier qualification status * Customers oversight: periodic customer License verification * Product Quality status and batch release or approval to the market * Local QC testing, CoA review and local release, when applicable * Analytical transfer coordination/approval to meet product launch, when applicable * Support compliance/quality issues with the impacted market team * Attends the market action fact finding meetings when required and implements the defined action plans within market * Ensures On Hold products request are observed * Coordinates and promptly perform any market action operation, recall, for medicinal products. Mock recalls * When acting as QRP back up / designee, decides on the final disposition of rejected, recalled or falsified products * When acting as QRP back up / designee, perform approval of the returns to saleable stock, according to BMS requirements * Support Supply Chain to avoid Back Orders * Provide quality input on shortage situations and oversight reporting to Health Authority * Medical samples Quality distribution oversight * Supports of sampling requested by HA (product, procedures, reference substances) * Keeps appropriate records of any delegated duties 3. Support implementation of BMS requirements in the Local UK /IE Distribution Centers for: * Warehousing facilities * Secondary packaging facilities * Transportation processes 4. Quality Risk Management * Coordination and preparation of Quality Risk Management * May participate in the periodic Business Review with the DC 5. Inspections and Regulatory Surveillance * Maintenance of the Wholesale Distributor License with Regulatory agency * Import certificates, when requested * Support the Global Quality Audits in the market * Preparation of HA inspection in local entity and leading HA inspection * Anticipate the new directives (Regulatory surveillance) Key Requirements: Bachelor's degree in Sciences, preferably in Pharmacy. 5 years of progressive experience within the quality function of the pharmaceutical health care industry. Knowledge and experience in pharmaceutical health care operations, quality control, distribution and International regulations are essential. Proficient