Bristol Myers Squibb

Associate Director, Quality Lead Benelux

1 week agoNivelles, Belgium

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.

Key Responsibilities and Major Duties:

1. Responsible Person for the Wholesale Distribution Authorization (WDA) of BMS Belgium and back up for BMS The Netherlands

  • Acts the local Responsible Person for medicinal products Distribution, in accordance with the local regulations

2. Ensure that a Quality Management System is implemented and maintained in the countries, including:
  • Maintains Quality System Documentation: procedures and records
  • BMS Policy/Directives/SOPs impact assessment and implementation
  • GDP and Local regulations impact assessment and implementation
  • Meeting the requirements of the defined Quality Unit activities
  • Ensures initial and continuous GMP/GDP training programs are implemented and maintained, including product identification and avoidance of falsified
  • Develops 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
  • Ensures implementation of Deviation and CAPA management
  • Ensures implementation of the Change Control management
  • Ensures reviews of the APQRs, as required per local regulations
  • Leads the Quality Management Review/Quality Council of the Market
  • Ensures reporting of quality metrics and implements adequate action plans for metrics achievement when necessary

3. Ensure Quality Operations are dealt with effectively:
  • Keep appropriate records of any delegated duties
  • Suppliers management oversight: Quality Agreements, approving any subcontracted activity which may impact on the product quality, evaluate and confirm the overview of the supplier qualification status
  • Customer oversight: periodic customer Licenses verification
  • Administrative batch release to the markets
  • Decision on the final disposition of, rejected, recalled or falsified products
  • Customer complaints handling
  • Handle compliance/quality issues with the impacted market
  • Attend the market action fact finding meeting, when required and define adequate action plans with the market
  • Ensure On Hold products requests are observed
  • Coordinate and promptly perform any market action operation, recall for medicinal products. Mock recalls.
  • Approval the returns to saleable stock, according to BMS guidelines
  • Support Supply chain to avoid Back Orders.
  • Provide quality input on shortages situations and oversight reporting to Health Authority
  • Medical samples Quality distribution oversight, if applicable

4. Facilitate BMS requirements are implemented in the Local Distribution Centre (DC) for:
  • Warehousing facilities
  • Secondary packaging facilities (when required to be used for exceptional operations)
  • Transportation processes

5. Quality Risk Management
  • Coordination and preparation of Quality Risk Management
  • Participate in the periodic Business Review with the local DC

6. Inspections and Regulatory Surveillance
  • Preparation of HA inspection in local entities and leading in HA inspection
  • Support the Global Quality Audits in the local markets
  • Anticipate the new directives (Regulatory surveillance) and proactively drive change

Key Requirements and Qualifications:
  • Must possess a Master's degree in Sciences, preferably in Pharmaceutical Sciences (or in (Veterinary) Medicine, Chemistry, Biology, Biomedical) to be in line with the local regulations
  • Demonstrated ability to develop and apply BMS operating philosophy and to operate within Company policies and procedures within Quality and Compliance area.
  • Good verbal, written and presentation skills in English, to deal effectively with all levels of management.
  • 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.
  • Demonstrated ability to switch priorities and manage more than one project at the time. Ability to plan and conduct in projects within a multi-disciplinary environment, inquisitive, science technology oriented individual but practical.
  • Demonstrated ability to influence, collaborate and communicate directly and to lead cross functional and cross regional teams.
  • Strong negotiating skills for interfacing with Health Authorities and market business functions.
  • Demonstrated ability to effectively communicate ideas, lead and persuade others to accomplish challenging goals and objectives
  • 7-10 years of progressive managerial experience within the quality function of the pharmaceutical health care industry or with regulatory agencies
  • Extensive knowledge and experience in pharmaceutical health care operations, quality control, distribution and International regulations are essential.
  • Proficient in cGMPs, GDPs and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies; ISO 9001:2000 regulations; and requirements for pharmaceutical products distribution.
  • French and English language skills

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.

Job ID: BristonMyers-R1537951