Quality Associate Manager (BeNeLux) - Bristol Myers Squibb - Braine-l'Alleud

Bristol-Myers Squibb

Région

Braine

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

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

Working Conditions:

Travel Required (nature and frequency): Occasionally

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Bristol-Myers Squibb

Société

Bristol-Myers Squibb