Quality Associate Manager (BeNeLux)

Quality Associate Manager (BeNeLux)

BMS - Bristol-Myers Squibb

Braine L'Alleud, Belgium

Purpose/Objective of the job:

  • Expected area of competence:
  • Supports the implementation and maintenance of quality management system, for the distribution activities with BMS product in the Market.
  • Escalates quality issues and decisions, which impact the business to the Responsible Person – Head of Quality Benelux
  • 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:

Ensure that a Quality Management System is implemented and maintained in the local market, including:

  • Supports and maintains Quality System Documentation: procedures and records
  • BMS Policy/Directives/SOPs impact assessment and implementation
  • GDP and Local regulations impact assessment and implementation
  • Supports initial and continuous GMP/GDP training programs, including product identification and avoidance of falsified
  • Supports update to and maintenance of the local Quality Manual
  • Ensures that relevant customer complaints are dealt with effectively
  • Supports the annual Self-Inspection Risk Assessment, Self-Inspection Plan and execution of self-inspections and puts in place necessary corrective measures
  • Supports and ensures deviation investigations and CAPA management impacting the BeNeLux markets
  • Supports the implementation of the Change Controls impacting BeNeLux markets
  • Supports the preparation of the Quality Management Review/Quality Council of the Markets
  • Reports quality metrics and monthly market updates, prepares Deep Dive Analysis for missed metrics

Ensures implementation of following Quality Operations:

  • Supports the Suppliers management oversight
  • Supports the Customers qualification process
  • Supports Responsible Person and back-up Responsible Person with Product Quality Administrative Batch Release
  • Supports quality issues with the impacted market team
  • Coordinates and promptly perform any market action operation, recall, for medicinal products. Mock recalls

Support implementation of BMS requirements in the Local Belgian/Dutch Distribution Centers for:

  • Warehousing facilities
  • Secondary packaging facilities
  • Transportation processes

Quality Risk Management

  • Support the coordination and preparation of Quality Risk Management

Inspections and Regulatory Surveillance

  • Support the Global Quality Audits in the market
  • Support preparation of HA inspection in local entity

Degree/Certification:

  • Must possess a Master's degree in Pharmaceutical Sciences (or in (Veterinary) Medicine, Chemistry, Biology, Biomedical), as defined in Art.95 § 2 of the RD of 14 Dec 2006

Experience – Responsibility and minimum number of years:

  • 3-5 years of progressive experience within the quality function of the pharmaceutical health care industry.
  • Knowledge and experience in pharmaceutical health care distribution, operations, quality assurance, and international regulations are essential.
  • Knowledge in GDPs and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies, and requirements for pharmaceutical products distribution.

Competencies – knowledge, skills, abilities, other:

  • 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 Values required: Passion, Innovation, Accountability, Integrity, Inclusion and Urgency
  • Good verbal, written and presentation skills in English.
  • 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.
  • Ability to effectively communicate ideas to accomplish challenging goals and objectives.

Supervisory Responsibility:

Supervision Received:

  • Works with supervision on the accomplishment of agreed upon goals and objectives

Supervision exercised:

  • Individual Contributor

Key Stakeholders/Contacts:

Internal:

  • Global Quality Functions, GPS functions, GRSB teams and Commercial organization including Operations, Brand teams, customer service team

External:

  • Government Regulatory Authorities and Third Party Suppliers and Vendors

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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