Supply Chain In-Market Associate Quality Manager
Bristol-Myers Squibb
Uxbridge, United Kingdom
2d ago

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 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.

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