Job Detail

Bei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu Innovationen bei, die bedeutende Veränderungen vorantreiben. Wir verleihen jeder Therapie, für die wir Pionierarbeit leisten, eine menschliche Note. Kommen Sie zu Bristol Myers Squibb  und machen Sie einen Unterschied.

Division

Global Product Development & Supply (GPS) - Global Quality, Research and Development Quality

Research and Development Quality (R&D Quality)

• Define and oversee the global quality strategy for early R&D Development up to phase IV Projects and ensure that GxP Quality Management Systems are implemented and in use


• Translate QMS elements into the R&D processes and ensure feedback to the central QMS team


• Lead the Quality and Compliance R&D Escalation Process


• Ensure GLP systems are in place, studies are audited and lead analytical path of Translational Medicine


• Oversee the Data generation and data integrity from laboratory work and non-clinical phase projects


• Ensure Quality is Designed into non-clinical trials and clinical protocols using data and information from discovery phase, non-clinical and clinical studies


• Oversee process development, manufacturing and release of clinical supplies to clinical trials protocols


• Advice on Franchises (including Cell Therapy) and Clinical Operations development projects


• Lead Qualification of vendors and manage external Quality Systems


• Execute GCP and Pharmacovigilance audits and support GCP and Pharmacovigilance Regulatory inspections


• Ensure that GxP follow-up CAPA activities are completed


• Oversee study centers, countries, investigators and connect with PV, Medical Affairs and Regulatory Affairs


• Contribute to develop Quality Management Systems training elements    

The PV and Lifecycle Management Quality pillar in RDQ provides independent quality oversight on the clinical safety/PV, RA and MA quality management systems applied during the lifecycle of products, managed by global internal and external stakeholders.

In addition to providing PV, RA, MA quality SME consultancy, the primary focus of the group are to:

• Continuously monitor the health of the QMS and initiate actions where needed;


• Watch Health Authority commitments, submission strategies and the planning/execution thereof;


• Manage/support PV inspections;


• Execute risk-based PV audits.

• Key Responsibilities and Major Duties

  Oversee and contribute to the quality management system relating to Clinical Safety/Pharmacovigilance, Regulatory and Medical Affairs activities, throughout the product lifecycle

   
  
  
  
  • Assess specific risk areas - brings ideas and strategies to the forefront and propose modifications to the QMS where necessary
  
  
  • Identify and drive continuous quality process improvements as a consequences of audits, assessments, inspections, trends/metrics and root cause analysis
  
  
  • Integrate end –to end quality principles.
  
  


• Establish strong partnership with business stakeholder
  
  
  
  • Seek to understand and evaluate their priorities
  
  
  • Actively participate in and make meaningful contributions
  
  
  • Deliver independent expert support and propose solutions
  
  
  • Present key data (compliance, conformance, issues and risks) to drive decision making
  
  


• Act as an expert and advise on clinical safety/ pharmacovigilance related matters:
  
  
  
  • Provide guidance and training on relevant GxP regulations and guidelines to cross-functional business partners.
  
  


• Manage critical and/or complex quality issues in the PV & LCM Quality remit, as assigned;


• Engage in appropriate activities to support and manage Health Authority PV inspections; as assigned;


• Execute audits, as assigned.



• Other



• Contributes to multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline


• Contribute to the implementation of large-scale initiatives and/or organizational changes (such as functional optimization) that affect the department


• Act as a credible technical/ functional expert; routinely provide technical/functional guidance/coaching to indirect reports/peers within the line or cross-lines


• Drive quality into the business through proactive quality support, mentoring and/or coaching and consultation.


• Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level


• Provide input in the global audit plans based on identified signals/trends/risks/gaps


• May influence the external environment through interactions with regulators, trade associations, or professional societies


• Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems


• (Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Degree Requirements

University Graduate, Life Sciences or Quality related degree preferred or equivalent combination of education, training and experience.

Experience Requirements

Demonstrated expertise and specific technical knowledge of clinical safety and pharmacovigilance, regulatory affairs and/or medical affairs activities of at least 8 years in the pharmaceutical industry or equivalent. Minimum of 5 years of PV operation experience and/or technical GVP/GCP auditing experience preferred.

Key Competency Requirements

• Demonstrated strong knowledge of global PV legislation and guidance, ICH/GCP,  clinical research, medical affairs and regulatory processes and principles of Quality Assurance


• Understanding of BMS’s therapeutic areas (Oncology, Cardiovascular, Hematology, Cell Therapy and Immunology and Fibrosis)


• Demonstrated applied knowledge of pre-and post-marketing regulatory requirements, as well as analytical, organizational and planning skills


• Broad knowledge of applied risk-management including risk assessment, risk analysis, risk evaluation, risk reporting and communication, risk treatment and the review of continuous risk management


• Experience in regulatory inspection preparation, management, and related follow-up


• Proven problem-solving skills to prevent and overcome complex process and quality related issues during clinical program implementation and execution


• Proficiency in utilizing data to generate insight and to formulate clear business questions that can be answered with data


• Communication Skills:  Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers; excellent presentation skills for compelling peer and Senior Management communication


• Project Management: Must be able to manage projects and  deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines


• Responds resourcefully to changing business conditions and opportunities, proactively looking for ways the organization can adapt its plans, tactics, or strategies.

Travel Required

Approximately 25% travel to perform audits and attend professional meetings and seminars.

Approximately 5 overnight absences per month.

Software that must be used independently and without assistance (e.g., Microsoft Suite)

Microsoft Suite, Veeva Vault QMS, SharePoint, other systems as assigned/applicable

Supervisory Responsibility (List job titles of positions that report directly or indirectly to this position and indicate nature of relationship)

None

Describe Exposure to Any Hazards/Disagreeable Conditions in the Work Environment

Not applicable.

Wir setzen uns auf der ganzen Welt leidenschaftlich dafür ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen. Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrität befähigen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das höchste Potenzial jedes unserer Kollegen hervor.

Bristol Myers Squibb weiß um die Bedeutung von Balance und Flexibilität im Arbeitsumfeld. Wir bieten daher eine Vielzahl von attraktiven Benefits, Dienstleistungen und Programmen an, die unseren Mitarbeitern die Ressourcen bieten, ihre Ziele sowohl bei der Arbeit als auch in ihrem Privatleben zu verfolgen.