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 :
Secondary packaging facilities
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 in GDPs and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies; ISO 9001 : 2000 regulations;
and requirements for pharmaceutical products distribution.
Ability to develop and apply BMS operating philosophy and to operate within Company policies and procedures within Quality and Compliance area.
Ability to apply BMS BioPharma Behaviors required : Passion, Innovation, Accountability and Speed.
Good verbal, written and presentation skills in English.
Innovative, creative and utilize available resources.
Strong working knowledge in PCs (experienced in Excel, Word, PowerPoint and SAP) and in Quality Systems.
Team oriented worker with excellent interpersonal skills.
Ability to actively participate in projects within a multi-disciplinary environment, inquisitive, science technology oriented individual but practical.
Ability to collaborate and communicate directly and to actively participate in cross functional and cross regional teams.
Negotiating skills for interfacing with Health Authorities and market business functions.
Ability to effectively communicate ideas and influence others to accomplish challenging goals and objectives.
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 the resources to pursue their goals, both at work and in their personal lives.